Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy, Tolerability, PK of OZ439 in Adults With Acute, Uncomplicated P.Falciparum or Vivax Malaria Mono-infection

This study has been completed.
Sponsor:
Collaborator:
Mahidol University
Information provided by (Responsible Party):
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT01213966
First received: October 1, 2010
Last updated: November 6, 2014
Last verified: November 2014
Results First Received: July 22, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Malaria, Falciparum
Malaria, Vivax
Intervention: Drug: OZ439

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited at two study centres in Thailand Primary study centre: Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand Sub-centre: Shoklo Malaria Research Unit, Mae Sod, Tak, Thailand The first patient was enrolled on 24 October 2010 and the last patient completed on 25 May 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no washout, run-in or transition following enrolment but prior to group assignment.

Reporting Groups
  Description
800 mg OZ439 po Single Dose Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
400 mg OZ439 p.o. Single Dose Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
200mg OZ439 p.o. Single Dose Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
1200 mg OZ439 po Single Dose Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose

Participant Flow:   Overall Study
    800 mg OZ439 po Single Dose     400 mg OZ439 p.o. Single Dose     200mg OZ439 p.o. Single Dose     1200 mg OZ439 po Single Dose  
STARTED     20     20     20     21  
COMPLETED     19     20     17     20  
NOT COMPLETED     1     0     3     1  
Protocol Violation                 1                 0                 3                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1 - OZ439 800mg 800 mg OZ439 po single dose
Cohort 2 - OZ439 400mg 400 mg OZ439 p.o. single dose
Cohort 3 - OZ439 200mg 200mg OZ439 p.o. single dose
Cohort 4 - OZ439 1200mg 1200 mg OZ439 po single dose
Total Total of all reporting groups

Baseline Measures
    Cohort 1 - OZ439 800mg     Cohort 2 - OZ439 400mg     Cohort 3 - OZ439 200mg     Cohort 4 - OZ439 1200mg     Total  
Number of Participants  
[units: participants]
  20     21     20     21     82  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     20     21     20     21     82  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.2  ± 8.37     29.1  ± 9.82     26.7  ± 9.75     29.3  ± 8.19     28.1  ± 8.97  
Gender  
[units: participants]
         
Female     2     4     1     4     11  
Male     18     17     19     17     71  
Region of Enrollment  
[units: participants]
         
Thailand     20     21     20     21     82  



  Outcome Measures

1.  Primary:   Derived Parasite Reduction Rate at 24 Hours (PPR24)   [ Time Frame: 24 hours after study drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Sasithon Pukrittayakamee
Organization: Faculty of Tropical Medicine
phone: (662) 354-9400-19 ext 1435
e-mail: yon@tropmedres.ac


No publications provided


Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT01213966     History of Changes
Other Study ID Numbers: MMV_OZ439_10_002
Study First Received: October 1, 2010
Results First Received: July 22, 2013
Last Updated: November 6, 2014
Health Authority: Thailand: Food and Drug Administration