Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers

This study has been terminated.
(Decision taken to halt progression of mefloquine as a potential partner for OZ439 as a single dose cure due to low probability of success)
Sponsor:
Collaborator:
University of Cape Town
Information provided by (Responsible Party):
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT01615822
First received: June 7, 2012
Last updated: March 27, 2015
Last verified: March 2015
Results First Received: March 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Malaria
Interventions: Drug: OZ439 100mg
Drug: OZ439 400mg
Drug: MQ 250 mg, single dose
Drug: MQ 750mg, single dose
Drug: Placebo

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort 1

Period 1: OZ439 100mg single dose oral suspension

Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet

Cohort 2

Period 1: OZ439 400mg single dose oral suspension

Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets

Placebo Placebo

Participant Flow for 2 periods

Period 1:   Period 1
    Cohort 1     Cohort 2     Placebo  
STARTED     8     11     6  
COMPLETED     7     9     6  
NOT COMPLETED     1     2     0  
Withdrawal by Subject                 0                 1                 0  
Adverse Event                 1                 1                 0  

Period 2:   Period 2
    Cohort 1     Cohort 2     Placebo  
STARTED     7     9     6  
COMPLETED     7     8     4  
NOT COMPLETED     0     1     2  
Lost to Follow-up                 0                 1                 2  



  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.
In Cohort 2, one subject withdrew consent prior to dosing and is therefore not part of the safety population.

Reporting Groups
  Description
Cohort 1

Period 1: OZ439 100mg single dose oral suspension

Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet

Cohort 2

Period 1: OZ439 400mg single dose oral suspension

Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets

Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    Cohort 1     Cohort 2     Placebo     Total  
Number of Participants  
[units: participants]
  8     10     6     24  
Age  
[units: years]
Mean ± Standard Deviation
  29.1  ± 10.3     30.6  ± 9.42     26  ± 4.45     28.6  ± 8.06  
Gender  
[units: participants]
       
Female     1     2     0     3  
Male     7     8     6     21  
Region of Enrollment  
[units: participants]
       
South Africa     8     10     6     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   OZ439 AUC0-t   [ Time Frame: Up to 42 days post-dose ]

2.  Secondary:   OZ439 Cmax   [ Time Frame: Up to 42 days post-dose ]

3.  Secondary:   MQ AUC0-t   [ Time Frame: Up to 42 days post-dose ]

4.  Secondary:   MQ Cmax   [ Time Frame: Up to 42 days 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 NOT 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.


Results Point of Contact:  
Name/Title: Fiona Macintyre, PhD
Organization: Medicines for Malaria Venture
phone: +41 22 555 0319
e-mail: macintyref@mmv.org


No publications provided


Responsible Party: Medicines for Malaria Venture
ClinicalTrials.gov Identifier: NCT01615822     History of Changes
Other Study ID Numbers: MMV_OZ439_12_001
Study First Received: June 7, 2012
Results First Received: March 17, 2015
Last Updated: March 27, 2015
Health Authority: South Africa: Medicines Control Council