Conditions: Malaria
Keywords: open label healthy volunteers pharmacokinetic parallel group
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 55
Healthy volunteers: yes

Brief summary:
A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

Detailed description:
A Phase 1 open label parallel group, four arm study conducted in healthy male and female subject aged 18 to 55 years of age. Subjects will receive either treatment A, B, C or D as described below:

* Treatment A: 1440 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment B: 960 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment C: 960 mg PQP granules for oral solution and 800 mg OZ439 + TPGS granules for oral suspension
* Treatment D: 800 mg OZ439 + TPGS granules for oral suspension

Arms:
arm 1: Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 2: Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 3: Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions. arm 4: OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.

Interventions: intervention 1: 1440mg PQP tablets intervention 2: 960mg PQP tablets intervention 3: 800mg OZ439 + TPGS intervention 4: 960mg PQP granules
Intervention descriptions: intervention 1: Piperaquine phosphate tablets (1440mg) intervention 2: Piperaquine phosphate tablets (960mg) intervention 3: OZ439 (800mg) + TPGS granules for oral suspension intervention 4: Piperaquine phosphate granules for oral solution (960mg)

Protocol document: