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A Study to Find the Minimum Inhibitory Concentration of KAE609 in Adult Male Patients With P. Falciparum Monoinfection

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: NCT01836458
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : October 31, 2016
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study aims to determine the Minimum Inhibitory Concentration of KAE609 in adult male patients with acute, uncomplicated malaria due to P.falciparum monoinfection after single dosing with KAE609

Condition or disease Intervention/treatment Phase
Malaria Drug: KAE609 Phase 2

Detailed Description:
There will be a total of approximately 45 patients recruited into this study and six doses of KAE609 and will be investigated.The dose groups will run in sequence. Patient will be given a single dose of KAE609 and be followed up for 42 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Study to Find the Minimum Inhibitory Concentration(MIC) of KAE609 in Adult Male Patients With Acute, Uncomplicated Malaria Due to Plasmodium Falciparum Monoinfection
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Dose 1: 30 mg
Single dose of KAE609 30 mg
Drug: KAE609
Patients will receive KAE609 single dose at a different dose level in each cohort.

Experimental: Dose 2: 20 mg
Single dose of KAE609 20 mg
Drug: KAE609
Patients will receive KAE609 single dose at a different dose level in each cohort.

Experimental: Dose 3: 10 mg
Single dose of KAE609 10 mg
Drug: KAE609
Patients will receive KAE609 single dose at a different dose level in each cohort.

Experimental: Dose 4: 15 mg
Single dose of KAE609 15 mg
Drug: KAE609
Patients will receive KAE609 single dose at a different dose level in each cohort.




Primary Outcome Measures :
  1. Minimum Inhibitory Concentration (MIC) of KAE609 [ Time Frame: Up to Day 8 after a single dose of KAE609 ]
    To observe the exposure-response (PK/PD) relationship for a single dose of KAE609. The key parameter is MIC, defined as the concentration at which the relative rate of change in parasitemia is equal to zero. Approximation of MIC will assist in identifying the optimal dose of KAE609, which will be one component of a future combination antimalarial. MIC could not be determined due to small sample size no data was collected from any participants.


Secondary Outcome Measures :
  1. Median Time to Parasite Clearance [ Time Frame: pre-dose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 20, 24, 30, 36, 42, 48, 54, 60, 66, 72 hours post dose of KAE609 ]
    Parasite clearance time will be estimated using thick/thin blood films.

  2. Median Time to Fever Clearance [ Time Frame: Day 1 to Day 5 ]
    Fever is monitored on participants every 4 hours for the first 24 hours, then every 6 hours until negative reading obtained.

  3. Percentage of Patients PCR-corrected Cure Rate by Day 28, Day 35 & Day 42 [ Time Frame: Day 28, Day 35 & Day 42 ]
    PCR-corrected cure rate after a single dose of KAE609 by Day 28, Day 35 & Day 42. PCR-corrected cure rate accounts for failures due to reappearance of parasites that were present in the blood before treatment (i.e. recrudescent infection) but not for failures due to a post-treatment inoculation (i.e. new infection).



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Monoinfection with P. falciparum confirmed by microscopy
  • Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
  • Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
  • Body weight between 40 to 90 kg

Key Exclusion Criteria:

  • Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
  • Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
  • Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
  • History of antimalarial use within 2 months of screening
  • Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
  • Long QT syndrome or QTc using Fridericia's formula >430 msec
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
  • Hemoglobin level <10 g/dL
  • Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
  • Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
  • Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
  • Known history of hepatitis B or C; testing is not required
  • Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
  • Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
  • Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
  • Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836458


Locations
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Vietnam
Novartis Investigative Site
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01836458    
Other Study ID Numbers: CKAE609A2201
First Posted: April 19, 2013    Key Record Dates
Results First Posted: October 31, 2016
Last Update Posted: October 31, 2016
Last Verified: September 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Malaria, KAE609
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases