A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT00928083
First received: June 24, 2009
Last updated: January 7, 2015
Last verified: January 2015
Results First Received: November 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Malaria Falciparum
Malaria Vivax
Healthy Volunteers
Interventions: Drug: OZ439 50mg API capsules
Drug: OZ439 200mg API capsules
Drug: OZ439 400mg aqueous dispersion
Drug: OZ439 800mg aqueous dispersion
Drug: OZ439 100mg API capsules
Drug: OZ439 400mg API capsules
Drug: OZ439 1600mg aqueous dispersion
Drug: OZ439 800mg API capsules
Drug: OZ439 1200mg API capsules
Drug: Placebo
Drug: OZ439 200mg aqueous dispersion

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Part A - OZ439 Single Dose - Cohort 1 OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
Part A - OZ439 Single Dose - Cohort 2 OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
Part A - OZ439 Single Dose - Cohort 3 Oral Dispersion OZ439 50-1600 mg
Part B - Food Effect - Cohort 1 Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
Part B - Food Effect - Cohort 2 Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
Part C - 200mg OZ439 Multiple Dose 200mg OZ439 for 3 consecutive days
Part C - 400mg OZ439 Multiple Dose OZ439 400mg for 3 consecutive days
Part C - 800mg OZ439 Multiple Dose OZ439 800mg for 3 consecutive days
Part C - Placebo Part C - Placebo

Participant Flow:   Overall Study
    Part A - OZ439 Single Dose - Cohort 1     Part A - OZ439 Single Dose - Cohort 2     Part A - OZ439 Single Dose - Cohort 3     Part B - Food Effect - Cohort 1     Part B - Food Effect - Cohort 2     Part C - 200mg OZ439 Multiple Dose     Part C - 400mg OZ439 Multiple Dose     Part C - 800mg OZ439 Multiple Dose     Part C - Placebo  
STARTED     10     8     8     6     7     6     6     6     6  
COMPLETED     6     8     8     5     6     6     6     6     6  
NOT COMPLETED     4     0     0     1     1     0     0     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Part A - OZ439 Single Rising Dose Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
Part B - OZ439 Food Effect Subjects were randomized to sequence groups, "fasted/fed or fed/fasted" while receiving a single dose of 800 mg OZ439.
Part C - OZ439 Multiple Rising Dose Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
Total Total of all reporting groups

Baseline Measures
    Part A - OZ439 Single Rising Dose     Part B - OZ439 Food Effect     Part C - OZ439 Multiple Rising Dose     Total  
Number of Participants  
[units: participants]
  26     13     24     63  
Age  
[units: years]
Mean ± Standard Deviation
  35.6  ± 10.35     33.7  ± 8.49     40.1  ± 10.17     36.5  ± 9.67  
Gender  
[units: participants]
       
Female     5     9     9     23  
Male     21     4     15     40  
Region of Enrollment  
[units: participants]
       
United States     26     13     24     63  



  Outcome Measures
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1.  Primary:   Adverse Events   [ Time Frame: From screening and at 10 (+/-2) days after last dose of study medication ]

2.  Secondary:   OZ439 AUC0-t   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]

3.  Secondary:   OZ439 AUC0-∝   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]

4.  Secondary:   OZ439 Cmax   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]

5.  Secondary:   OZ439 Tmax   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]

6.  Secondary:   OZ439 t1/2   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]

7.  Secondary:   OZ439 Rac   [ Time Frame: Samples collected from Pre-dose up to 96h post dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Joerg Moehrle
Organization: Medicines for Malaria Venture
phone: +41 22 555 0330
e-mail: moehrlej@mmv.org


Publications of Results:

Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT00928083     History of Changes
Other Study ID Numbers: MMV_OZ439_09_001
Study First Received: June 24, 2009
Results First Received: November 10, 2014
Last Updated: January 7, 2015
Health Authority: United States: Food and Drug Administration