Conditions: Malaria
Keywords: Malaria PK OZ439 Mefloquine Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: yes

Brief summary:
OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.

Detailed description:

Arms:
arm 1: OZ439 100mg single dose oral suspension arm 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet arm 3: OZ439 400mg single dose oral suspension arm 4: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets arm 5: Placebo

Interventions: intervention 1: OZ439 100mg intervention 2: OZ439 400mg intervention 3: MQ 250 mg, single dose intervention 4: MQ 750mg, single dose intervention 5: Placebo
Intervention descriptions: intervention 1: OZ439 100mg oral suspension, single dose intervention 2: OZ439 400mg oral suspension, single dose intervention 3: Mefloquine 250 mg tablet, single dose intervention 4: Mefloquine 750mg oral tablet, single dose intervention 5: None

Protocol document: