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To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria (FALCI)

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ClinicalTrials.gov Identifier: NCT02497612
Recruitment Status : Terminated (All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.)
First Posted : July 14, 2015
Results First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Plasmodium Falciparum Infection
Interventions Drug: Ferroquine SSR97193
Drug: Artefenomel
Other: Placebo
Enrollment 377
Recruitment Details Study conducted at 12 active sites in 7 countries. Total of 806 participants were screened between 25 July 2015 and 22 July 2019, of which 377 were randomized to 1 of 4 treatment arms (via Integrated Web Recognition System using permuted block randomization schedules). 429 participants failed screening mainly due to meeting exclusion criteria.
Pre-assignment Details In each arm, participants were divided in 4 cohorts (C):C1 (greater than [>] 14 years (yrs) to less than [<] 70 yrs); C2 (>5 yrs to less than or equal to [<=] 14 yrs );C3 (>2 yrs to <=5 yrs); C4 (>6 months to <=2 yrs). Day 0 (drug administration day, per protocol) was Day 1 for safety reporting as per Clinical Data Interchange Standards Consortium.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description On Day 0, based on the body weight (BW), participants received orally a single dose of ferroquine (FQ) capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of artefenomel (OZ439) (maximum dose up to 800 milligrams [mg]) oral suspension as follows: BW greater than or equal to (>=) 35 kilograms (kg): FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Period Title: Overall Study
Started 93 94 97 93
Treated 92 94 96 91
Cohort 1: >14 Years to <70 Years 14 15 18 16
Cohort 2: >5 Years to <=14 Years 6 5 6 5
Cohort 3: >2 Years to <=5 Years 66 66 67 65
Cohort 4: >6 Months to <=2 Years 7 8 6 7
Completed 27 37 48 46
Not Completed 66 57 49 47
Reason Not Completed
Met >=1 anti-malarial treatment criteria             57             51             39             41
Participant's request             2             3             4             1
Investigator's judgement             1             0             0             2
Adverse Event             3             1             4             1
Lost to Follow-up             1             1             0             1
Other unspecified             1             1             2             0
Not eligible             1             0             0             1
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg) Total
Hide Arm/Group Description On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg Total of all reporting groups
Overall Number of Baseline Participants 93 94 97 93 377
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 94 participants 97 participants 93 participants 377 participants
7.34  (9.94) 6.97  (8.97) 7.61  (9.60) 7.68  (10.44) 7.40  (9.71)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 97 participants 93 participants 377 participants
>6 months to <=2 years 7 8 6 7 28
>2 to <=5 years 66 66 67 65 264
>5 to <=14 years 6 5 6 5 22
>14 to <18 years 6 5 7 4 22
>=18 years 8 10 11 12 41
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 97 participants 93 participants 377 participants
Female
37
  39.8%
46
  48.9%
43
  44.3%
56
  60.2%
182
  48.3%
Male
56
  60.2%
48
  51.1%
54
  55.7%
37
  39.8%
195
  51.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 94 participants 97 participants 93 participants 377 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   4.3%
5
   5.3%
6
   6.2%
6
   6.5%
21
   5.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
89
  95.7%
89
  94.7%
91
  93.8%
87
  93.5%
356
  94.4%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With Polymerase Chain Reaction (PCR)-Adjusted Adequate Clinical and Parasitological Response (ACPR) at Day 28: African <=5 Years Per Protocol Population at Day 28 (PP28)
Hide Description ACPR: negative parasitemia at Day 28, irrespective of axillary temperature(AT), in participants not meeting any criteria of early therapy failure (ETF):Danger signs (DS)/severe malaria (SM) at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count >Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5 degree Celsius (°C); or parasite count on Day 3>=25 percent (%) on Day 0, or late clinical failure(LCF):DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT>=37.5°C between Day 4 and 28, or late parasitological failure (LPF):presence of parasitemia between Day 7 and 28 and AT<37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with genotype identical to that present at Baseline), excluding participants with re-infection. In data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
African <=5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 51 60 57 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
78.4
(64.7 to 88.7)
85.0
(73.4 to 92.9)
89.5
(78.5 to 96.0)
91.7
(81.6 to 97.2)
2.Secondary Outcome
Title Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: African >5 Years Per Protocol Population at Day 28 (A5PP28)
Hide Description ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
African >5 years PP28: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 11 10 12 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.7
(39.0 to 94.0)
100
(69.2 to 100)
100
(73.5 to 100)
90.0
(55.5 to 99.7)
3.Secondary Outcome
Title Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 28: Asian PP Population at Day 28 (APP28)
Hide Description ACPR: negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28, or LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Asian PP28 population: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 28, excluding those who received rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 4 4 5 5
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.0
(0.6 to 80.6)
25.0
(0.6 to 80.6)
40.0
(5.3 to 85.3)
20.0
(0.5 to 71.6)
4.Secondary Outcome
Title Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP Population at Day 42 (PP42)
Hide Description ACPR: negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42, or LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
African <=5 years PP42: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 42, excluding those who received rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 43 55 50 57
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69.8
(53.9 to 82.8)
81.8
(69.1 to 90.9)
84.0
(70.9 to 92.8)
87.7
(76.3 to 94.9)
5.Secondary Outcome
Title Percentage of Participants With Polymerase Chain Reaction-adjusted Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP Population at Day 63 (PP63)
Hide Description ACPR: negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63, or LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR was applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection. Here, in the data table, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
African <=5 years PP63: participants with parasitologically confirmed Plasmodium falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at Day 63, excluding those who received rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 39 43 44 47
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
64.1
(47.2 to 78.8)
76.7
(61.4 to 88.2)
81.8
(67.3 to 91.8)
87.2
(74.3 to 95.2)
6.Secondary Outcome
Title Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 28: African <=5 Years PP28 Population
Hide Description ACPR was defined as negative parasitemia at Day 28, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 28; or presence of parasitemia and AT >=37.5°C between Day 4 and 28 or, LPF: presence of parasitemia between Day 7 and 28 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR does not distinguish re-infection (new clone of parasite) or recrudescence.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years PP28 population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 67 63 62
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.3
(37.0 to 61.6)
71.6
(59.3 to 82.0)
76.2
(63.8 to 86.0)
87.1
(76.1 to 94.3)
7.Secondary Outcome
Title Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 42: African <=5 Years PP42 Population
Hide Description ACPR was defined as negative parasitemia at Day 42, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 42; or presence of parasitemia and AT >=37.5°C between Day 4 and 42 or, LPF: presence of parasitemia between Day 7 and 42 and AT <37.5°C or having rescue therapy for malaria PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years PP42 population.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 65 59 61
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
39.1
(27.6 to 51.6)
50.8
(38.1 to 63.4)
61.0
(47.4 to 73.5)
68.9
(55.7 to 80.1)
8.Secondary Outcome
Title Percentage of Participants With Crude Adequate Clinical and Parasitological Response at Day 63: African <=5 Years PP63 Population
Hide Description Crude ACPR was defined as negative parasitemia at Day 63, irrespective of AT, in participants not meeting any criteria of ETF: DS or SM at Day 1, 2 or 3 in presence of parasitemia; or Day 2 parasite count > Day 0 irrespective of AT; or parasitemia at Day 3 with AT >=37.5°C; or parasite count on Day 3 >=25% on Day 0, or LCF: DS/ SM in presence of parasitemia between Day 4 and 63; or presence of parasitemia and AT >=37.5°C between Day 4 and 63 or, LPF: presence of parasitemia between Day 7 and 63 and AT <37.5°C or having rescue therapy for malaria. PCR-adjusted ACPR applied to recrudescence (appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline), excluding participants with re-infection, whereas crude ACPR did not distinguish re-infection (new clone of parasite) or recrudescence.
Time Frame Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years PP63 population.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 68 65 59 60
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
35.3
(24.1 to 47.8)
46.2
(33.7 to 59.0)
57.6
(44.1 to 70.4)
58.3
(44.9 to 70.9)
9.Secondary Outcome
Title Time to Re-emergence
Hide Description Time to re-emergence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection irrespective of genotype. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Re-emergence was confirmed by microscopy (positive blood smear). Kaplan-Maier method was used for estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Time Frame Up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
African <=5 years modified Intent-To-Treat (mITT) population: all randomized African participants <=5 years with parasitological confirmed Plasmodium falciparum (P. falciparum) malaria at baseline, who received the single administration of OZ439/FQ and excluding participants who required rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 73 70 69
Median (95% Confidence Interval)
Unit of Measure: days
36.0
(24.00 to 63.00)
61.0 [1] 
(43.00 to NA)
NA [2] 
(NA to NA)
64.0
(63.00 to 65.00)
[1]
Upper limit of 95% confidence interval (CI) was not estimable due to very low number of participants with the events.
[2]
Median and 95% CI was not estimable due to very low number of participants with the events.
10.Secondary Outcome
Title Time to Recrudescence
Hide Description Time to recrudescence (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype identical to that of parasites present at Baseline. Recrudescence was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.
Time Frame Up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 73 70 69
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to very low number of participants with the events.
11.Secondary Outcome
Title Time to Re-infection
Hide Description Time to re-infection (in days) was defined as the time to appearance of asexual parasites after clearance of initial infection with a genotype that differs from that of parasites present at Baseline. Re-infection was confirmed by PCR analysis. Kaplan-Maier method was used for estimation.
Time Frame Up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years mITT population. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 73 70 69
Median (95% Confidence Interval)
Unit of Measure: days
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
65.0 [2] 
(NA to NA)
[1]
Median and 95% CI was not estimable due to very low number of participants with the events.
[2]
95% CI was not estimable due to very low number of participants with the events.
12.Secondary Outcome
Title Parasite Clearance Time (PCT): African <=5 Years PP Population
Hide Description PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, in the data table "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Time Frame From the start of study drug administration up to the time of the first negative film (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
African<=5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 69 67 63 62
Median (95% Confidence Interval)
Unit of Measure: hours
36.0
(24.23 to 36.07)
36.0
(35.93 to 36.10)
36.1
(36.00 to 48.00)
36.1
(24.25 to 36.42)
13.Secondary Outcome
Title Parasite Clearance Time: African >5 Years PP Population
Hide Description PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Time Frame From the start of study drug administration up to the time of the first negative film (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
African >5years PP population participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violation impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 11 11 12 10
Median (95% Confidence Interval)
Unit of Measure: hours
24.0
(18.00 to 24.18)
24.3
(18.07 to 36.00)
24.3
(12.23 to 36.00)
27.2
(6.15 to 36.17)
14.Secondary Outcome
Title Parasite Clearance Time: Asian PP Population
Hide Description PCT was defined as the time (in hours) from the start of study drug administration until the time of first negative blood film (no asexual parasites). This first negative film was confirmed by a second negative film which was taken >=6 to <=12 hours of the first film. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Time Frame From the start of study drug administration up to the time of the first negative film (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
Asian PP population: participants with parasitologically confirmed P.falciparum malaria at screening/baseline, received the single administration of OZ439/FQ, without major protocol violations impacting efficacy, evaluable for crude ACPR at pre-defined time point, excluding who had rescue treatment due to vomiting during drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 4 5 5 5
Median (95% Confidence Interval)
Unit of Measure: hours
82.0 [1] 
(79.97 to NA)
75.1
(53.93 to 95.82)
79.8 [1] 
(36.00 to NA)
72.2
(60.08 to 79.98)
[1]
Upper limit of 95% CI was not estimable due to very low number of participants with the events.
15.Secondary Outcome
Title Fever Clearance Time (FCT): African <=5 Years PP Population
Hide Description FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first assessment. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.
Time Frame From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed performed on African <=5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 5 3 4 4
Median (95% Confidence Interval)
Unit of Measure: hours
1.0
(1.00 to 24.00)
1.0
(1.00 to 18.00)
1.0 [1] 
(NA to NA)
1.0
(1.00 to 12.00)
[1]
95% CI was not estimable as all 4 participants had the same value.
16.Secondary Outcome
Title Fever Clearance Time: African >5 Years PP Population
Hide Description FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation.
Time Frame From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African >5 years PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had event, plus those who were censored.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 3 1 2 1
Median (95% Confidence Interval)
Unit of Measure: hours
1.0
(1.00 to 18.00)
1.0
1.5
(1.00 to 2.00)
2.0
17.Secondary Outcome
Title Fever Clearance Time: Asian PP Population
Hide Description FCT was defined as the time (in hours) from start of study drug administration to the first assessment of adjusted body temperature <37.5°C, confirmed by second assessment, taken within >=6 to <=12 hours of the first. Only participants with fever (adjusted body temperature >=37.5°C present at Baseline) and did not receive paracetamol on day of study drug administration until 96 hours after study drug administration were included in FCT analysis. Participants with no event were censored at the time of study completion, premature study discontinuation, including switch to established anti-malarial treatment or start of any other treatment with anti-malarial activity, whichever was earliest. Kaplan-Meier method was used for the estimation. Here, "overall number of participants analyzed"=participants who were included in the analysis of below reported results which consisted of both, who had the event, plus those who were censored.
Time Frame From the start of study drug administration up to the time of the first temperature measurement <37.5°C (up to Day 63)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Asian PP population participants with fever and did not receive paracetamol within 96 hours of study drug administration. Here, '0' in "overall number of participants analyzed"=no participants were evaluable since they had paracetamol within 96 hours of study drug administration.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 1 0 0 1
Median (95% Confidence Interval)
Unit of Measure: hours
18.0 36.0
18.Secondary Outcome
Title Parasite Reduction Ratio (PRRlog10) at 24 Hours and 48 Hours: African <=5 Years PP Population
Hide Description The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.
Time Frame 24 and 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African <=5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 63 57 58 53
Median (95% Confidence Interval)
Unit of Measure: ratio
PRR24 (log10)
2.867
(1.19 to 5.35)
3.011
(1.10 to 5.63)
2.397
(1.25 to 4.75)
2.587
(1.52 to 5.24)
PRR48 (log10)
5.734
(2.39 to 10.69)
6.023
(2.20 to 11.27)
4.794
(2.50 to 9.50)
5.174
(3.04 to 10.48)
19.Secondary Outcome
Title Parasite Reduction Ratio at 24 Hours and 48 Hours: African >5 Years PP Population
Hide Description The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.
Time Frame 24 and 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on African >5 years PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 7 9 10 8
Median (Full Range)
Unit of Measure: ratio
PRR24 (log10)
2.979
(2.41 to 4.30)
4.069
(2.16 to 5.00)
3.288
(2.30 to 4.81)
3.054
(1.76 to 5.59)
PRR48 (log10)
5.957
(4.83 to 8.60)
8.137
(4.32 to 10.00)
6.577
(4.61 to 9.63)
6.108
(3.52 to 11.17)
20.Secondary Outcome
Title Parasite Reduction Ratio at 24 Hours and 48 Hours: Asian PP Population
Hide Description The PRR was calculated as the slope of the linear portion of the regression fit of logarithm parasitemia (per milliliter) versus time (in hours). The PRR24 and PRR48 was the drop-in log units over 24 and 48 hours, respectively.
Time Frame 24 and 48 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on Asian PP population. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 4 5 4 4
Median (Full Range)
Unit of Measure: ratio
PRR24 (log10)
1.167
(1.01 to 1.28)
1.125
(1.00 to 1.44)
1.688
(1.07 to 3.12)
1.353
(1.10 to 1.65)
PRR48 (log10)
2.335
(2.03 to 2.56)
2.250
(1.99 to 2.88)
3.377
(2.14 to 6.24)
2.705
(2.21 to 3.31)
21.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESI)
Hide Description An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily had to have a causal relationship with the treatment. SAEs were any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment phase that was defined as the time from the start of the first dose of double-blind drug administration up to the Day 63. AE of special interest (AESI) was an AE (serious or non-serious) of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and immediate notification by the Investigator to the Sponsor was required.
Time Frame From Baseline up to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed on safety population which included all randomized participants who received at least 1 dose or part of a dose of the study medication.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 92 94 96 91
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
84
  91.3%
87
  92.6%
85
  88.5%
81
  89.0%
Any treatment-emergent SAE
0
   0.0%
2
   2.1%
4
   4.2%
2
   2.2%
Any treatment-emergent AESI
5
   5.4%
8
   8.5%
9
   9.4%
11
  12.1%
Any TEAE led to treatment discontinuation
3
   3.3%
2
   2.1%
3
   3.1%
2
   2.2%
Any TEAE led to death
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax) of Artefenomel
Hide Description Cmax is the maximum observed plasma concentration of artefenomel.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the PK population for OZ439 which included all participants who received OZ439 and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 88 93 93 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter
1072
(95%)
936.7
(91%)
771.8
(92%)
797.8
(119%)
23.Secondary Outcome
Title Pharmacokinetics: Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Artefenomel
Hide Description Area under the plasma concentration versus time curve from time zero to infinity.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population for OZ439.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 88 93 93 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour per milliliter
14.24
(124%)
12.41
(127%)
9.621
(130%)
9.605
(147%)
24.Secondary Outcome
Title Pharmacokinetics (PK): Apparent Total Clearance of Artefenomel From Plasma After Oral Administration
Hide Description Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and pharmacodynamic [PD]). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration (Vss/F) of Artefenomel
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title Pharmacokinetics: Maximum Observed Plasma Concentration of Ferroquine (Cmax)
Hide Description Cmax is the maximum observed plasma concentration of Ferroquine.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on the PK population for FQ which included all participants who received FQ and had at least one evaluable blood sample for PK and with adequate documentation of dosing date and sampling date. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 88 93 93 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms per milliliter
148.1
(52%)
222.8
(66%)
350
(55%)
467.6
(80%)
27.Secondary Outcome
Title Pharmacokinetics: Area Under the Curve From Time 0 to Day 28 (AUC0-day28) of Ferroquine
Hide Description Area under the plasma concentration versus time curve from time 0 to Day 28 (i.e. 672 hours).
Time Frame 2, 4, 6, 8, 12, 24, 48, 168, 336 and 672 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on PK population for FQ. Here, "overall number of participants analyzed"=participants evaluable for this outcome measure.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 88 93 93 90
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms*hour per milliliter
14.92
(40%)
22.56
(48%)
33.84
(48%)
46.4
(52%)
28.Secondary Outcome
Title Pharmacokinetics: Apparent Total Clearance of Ferroquine From Plasma After Oral Administration
Hide Description Clearance is defined as a quantitative measure of the rate at which a drug substance is removed from the body.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since clearance was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Pharmacokinetics: Apparent Volume of Distribution at Steady State After Non-intravenous Administration of Ferroquine
Hide Description Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since volume of distribution was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Pharmacokinetics: Blood/Plasma Ratio for Ferroquine and Its Active Metabolite SSR97213
Hide Description [Not Specified]
Time Frame 2, 4, 6, 12, 24, 48, 72 and 672 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
Focus of PK assessment was to support the analysis of exposure versus efficacy relationship (PK and PD). Since blood plasma ratio of active drug and metabolite was considered irrelevant to the objective of the PK and exposure-response analyses, therefore data for this outcome measure were not collected and reported.
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description:
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg.
On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From Baseline up to Day 63
Adverse Event Reporting Description Reported AEs were TEAEs, defined as AEs that developed/worsened or became serious during on-treatment phase - defined as the time from the start of the first dose of double-blind drug administration up to Day 63. Analysis was performed on safety population.
 
Arm/Group Title Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Hide Arm/Group Description On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg oral suspension as follows: BW >= 35 kg: FQ 400 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 300 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 200 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 150 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 100 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 75 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 600 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 450 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 300 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 225 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 150 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 115 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 900 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 675 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 450 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 335 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 225 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 170 mg + OZ439 150 mg. On Day 0, based on the BW, participants received orally a single dose of FQ capsules or oral suspension (along with matching placebo, as applicable to maintain blinding) and a single dose of OZ439 (maximum dose up to 800 mg) oral suspension as follows: BW >= 35 kg: FQ 1200 mg + OZ439 800 mg; BW >=24 kg to <35 kg: FQ 900 mg + OZ439 600 mg; BW >=15 kg to <24 kg: FQ 600 mg + OZ439 400 mg; BW >=10 kg to <15 kg: FQ 450 mg + OZ439 300 mg; BW >=7 kg to <10 kg: FQ 300 mg + OZ439 200 mg; >=5 kg to <7kg: FQ 225 mg + OZ439 150 mg.
All-Cause Mortality
Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/92 (0.00%)      0/94 (0.00%)      0/96 (0.00%)      0/91 (0.00%)    
Hide Serious Adverse Events
Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/92 (0.00%)      2/94 (2.13%)      4/96 (4.17%)      2/91 (2.20%)    
Hepatobiliary disorders         
Drug-Induced Liver Injury  1  0/92 (0.00%)  0 0/94 (0.00%)  0 1/96 (1.04%)  1 0/91 (0.00%)  0
Infections and infestations         
Malaria  1  0/92 (0.00%)  0 1/94 (1.06%)  1 1/96 (1.04%)  1 0/91 (0.00%)  0
Hepatitis A  1  0/92 (0.00%)  0 0/94 (0.00%)  0 0/96 (0.00%)  0 1/91 (1.10%)  1
Pharyngitis  1  0/92 (0.00%)  0 1/94 (1.06%)  1 0/96 (0.00%)  0 0/91 (0.00%)  0
Investigations         
Alanine Aminotransferase Increased  1  0/92 (0.00%)  0 0/94 (0.00%)  0 2/96 (2.08%)  2 0/91 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pneumonia Aspiration  1  0/92 (0.00%)  0 0/94 (0.00%)  0 0/96 (0.00%)  0 1/91 (1.10%)  1
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ferroquine (up to 400 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 600 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 900 mg) + Artefenomel (up to 800 mg) Ferroquine (up to 1200 mg) + Artefenomel (up to 800 mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   77/92 (83.70%)      79/94 (84.04%)      77/96 (80.21%)      74/91 (81.32%)    
Gastrointestinal disorders         
Vomiting  1  27/92 (29.35%)  29 27/94 (28.72%)  28 34/96 (35.42%)  37 34/91 (37.36%)  37
Diarrhoea  1  10/92 (10.87%)  10 11/94 (11.70%)  12 7/96 (7.29%)  9 11/91 (12.09%)  13
Abdominal Pain  1  7/92 (7.61%)  7 5/94 (5.32%)  5 5/96 (5.21%)  5 6/91 (6.59%)  6
General disorders         
Pyrexia  1  7/92 (7.61%)  9 2/94 (2.13%)  3 9/96 (9.38%)  12 10/91 (10.99%)  10
Infections and infestations         
Malaria  1  55/92 (59.78%)  75 50/94 (53.19%)  65 40/96 (41.67%)  49 41/91 (45.05%)  45
Upper Respiratory Tract Infection  1  7/92 (7.61%)  9 6/94 (6.38%)  8 17/96 (17.71%)  18 10/91 (10.99%)  10
Bronchitis  1  3/92 (3.26%)  3 5/94 (5.32%)  5 4/96 (4.17%)  4 5/91 (5.49%)  5
Rhinitis  1  4/92 (4.35%)  4 3/94 (3.19%)  4 1/96 (1.04%)  1 7/91 (7.69%)  8
Investigations         
Electrocardiogram Qt Prolonged  1  6/92 (6.52%)  6 5/94 (5.32%)  5 6/96 (6.25%)  7 8/91 (8.79%)  8
Metabolism and nutrition disorders         
Decreased Appetite  1  5/92 (5.43%)  6 8/94 (8.51%)  8 5/96 (5.21%)  5 5/91 (5.49%)  5
Nervous system disorders         
Headache  1  6/92 (6.52%)  6 7/94 (7.45%)  8 7/96 (7.29%)  8 5/91 (5.49%)  6
Respiratory, thoracic and mediastinal disorders         
Cough  1  10/92 (10.87%)  13 7/94 (7.45%)  9 15/96 (15.63%)  16 15/91 (16.48%)  17
1
Term from vocabulary, MedDRA 22.1
Indicates events were collected by systematic assessment
The study was terminated early because all treatment arms met the futility criteria for efficacy during the pre-planned interim analysis. On 02-August-2018, recruitment in Asia was stopped due to lack of efficacy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
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Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02497612    
Other Study ID Numbers: DRI12805
U1111-1155-7960 ( Other Identifier: UTN )
First Submitted: July 8, 2015
First Posted: July 14, 2015
Results First Submitted: September 22, 2020
Results First Posted: October 19, 2020
Last Update Posted: October 19, 2020