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Healthy Volunteer Study of the Pharmacokinetics of Oral Piperaquine With OZ439 + TPGS Formulation in the Fasted State

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853475
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : April 8, 2015
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
Richmond Pharmacology Limited
Information provided by (Responsible Party):
Medicines for Malaria Venture

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malaria
Interventions Drug: PQP tablets 960mg
Drug: PQP tablets 1440mg
Drug: OZ439+TPGS 800mg
Drug: OZ439 PIB 800mg
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Period Title: Overall Study
Started 8 8 8
Completed 8 7 8
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg Total
Hide Arm/Group Description PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 24
Hide Baseline Analysis Population Description
All 24 subjects who had received at least one treatment of randomised study medication and for whom any post-treatment data was available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 24 participants
33.5  (13.06) 30.1  (6.33) 30.1  (5.79) 31.3  (8.77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 24 participants
Female
1
  12.5%
0
   0.0%
0
   0.0%
1
   4.2%
Male
7
  87.5%
8
 100.0%
8
 100.0%
23
  95.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 8 participants 8 participants 8 participants 24 participants
8 8 8 24
1.Primary Outcome
Title OZ439 Cmax
Hide Description OZ439 maximum concentration observed
Time Frame Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description:
PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
1540
(26.0%)
1360
(33.8%)
1610
(37.2%)
2.Primary Outcome
Title OZ439 AUC0-inf
Hide Description Area under the OZ439 plasma concentration time curve from time zero to time infinity using observed values.
Time Frame Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description:
PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
17500
(27.9%)
16000
(24.7%)
18600
(45.4%)
3.Secondary Outcome
Title Piperaquine Cmax
Hide Description Piperaquine maximum concentration observed
Time Frame Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description:
PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
202
(37.6%)
122
(42.1%)
630
(54.4%)
4.Secondary Outcome
Title Piperaquine AUC0-inf
Hide Description Area under the Piperaquine plasma concentration time curve from time zero to time infinity using observed values.
Time Frame Day 1 pre-dose and post-dose at 0.5, 1, 2, 3, 4, 5, 6, 8, 12, 16 and 24 hours(Day 2), and, 48 (Day 3), 72 (Day 4), 96 (Day 5),168 (Day 8), Day 11, Day 15, Day 29 and Day 43
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters were evaluated using all available concentration data from all 24 subjects who had received at least one treatment of randomised study medication.
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description:
PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
Overall Number of Participants Analyzed 8 8 8
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
17200
(29.5%)
13400
(23.1%)
29700
(48.0%)
Time Frame Up to Day 43 post-dose.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Hide Arm/Group Description PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted. PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
All-Cause Mortality
Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/8 (0.00%)      0/8 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Treatment A: PQP 1440mg & OZ439+TPGS 800mg Treatment B: PQP 960mg & OZ439+TPGS 800mg Treatment C - PQP 1440mg & OZ439 PIB 800mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/8 (75.00%)      4/8 (50.00%)      5/8 (62.50%)    
Blood and lymphatic system disorders       
Lymphadenopathy * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Gastrointestinal disorders       
Nausea * 1  4/8 (50.00%)  4 1/8 (12.50%)  1 0/8 (0.00%)  0
Salivary hypersecretion * 1  0/8 (0.00%)  0 2/8 (25.00%)  2 0/8 (0.00%)  0
Vomiting * 1  2/8 (25.00%)  2 0/8 (0.00%)  0 0/8 (0.00%)  0
Abdominal discomfort * 1  0/8 (0.00%)  0 1/8 (12.50%)  1 0/8 (0.00%)  0
Change of bowel habit * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
General disorders       
Influenza like illness * 1  3/8 (37.50%)  3 1/8 (12.50%)  1 3/8 (37.50%)  3
Fatigue * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Immune system disorders       
Seasonal Allergy * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Nervous system disorders       
Headache * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 3/8 (37.50%)  3
Dizziness * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Psychiatric disorders       
Nightmare * 1  0/8 (0.00%)  0 0/8 (0.00%)  0 1/8 (12.50%)  1
Renal and urinary disorders       
Urine odour abnormal * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
Reproductive system and breast disorders       
Vaginal haemorrhage * 1  1/8 (12.50%)  1 0/8 (0.00%)  0 0/8 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (15.1)
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.
After completion of the study, the Investigator may prepare a joint publication with the Sponsor. The Investigator must undertake not to submit any part of the individual data from this protocol for publication without prior consent of the Sponsor at a mutually agreed time.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Thomas Rueckle
Organization: Medicines for Malaria Ventire (MMV)
Phone: +41 22 799 4567
EMail: ruecklet@mmv.org
Layout table for additonal information
Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT01853475    
Other Study ID Numbers: MMV_OZ439_13_002
2013-000983-28 ( EudraCT Number )
First Submitted: May 10, 2013
First Posted: May 15, 2013
Results First Submitted: March 27, 2015
Results First Posted: April 8, 2015
Last Update Posted: April 30, 2015