Conditions: Healthy
Keywords: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 59
Healthy volunteers: yes

Brief summary:
A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Detailed description:
Placebo-controlled, double-blind, five-cohort, 2-period (per cohort) dose-escalation study.

For each subject, the study included a screening evaluation (within 21 days of the 1st dose), dosing on 2 separate occasions (Period 1 and Period 2) and a follow-up visit (6 weeks following the final dose).

Within each cohort, subjects were randomised into two sequences to receive OZ439 in Period 1 and OZ439 plus piperaquine in Period 2 (sequence 1, 8 subjects) or OZ439-matching placebo in Period 1 and OZ439/piperaquine matching placebos in Period 2 (sequence 2, 4 subjects).

Safety and tolerability were evaluated: Physical examination, ECG assessments including a full baseline matched profile of ECG tracings, vital signs, laboratory evaluations, in particular liver function tests and adverse events.

Arms:
arm 1: 100mg OZ439 single oral dose arm 2: 100mg OZ439 single oral dose + 160mg Piperaquine single oral dose arm 3: 100mg OZ439 single oral dose + 480mg Piperaquine single oral dose arm 4: 100mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 5: 300mg OZ439 single oral dose arm 6: 300mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 7: 800mg OZ439 single oral dose arm 8: 800mg OZ439 single oral dose + 1440mg Piperaquine single oral dose arm 9: Placebo

Interventions: intervention 1: 100mg OZ439 single oral dose intervention 2: Placebo intervention 3: 300 mg OZ439 single oral dose intervention 4: 160mg Piperaquine single oral dose intervention 5: 480mg Piperaquine single oral dose intervention 6: 1440mg Piperaquine single oral dose intervention 7: 800 mg OZ439 single oral dose
Intervention descriptions: intervention 1: 100mg OZ439 oral suspension single dose intervention 2: Placebo intervention 3: 300mg OZ439 oral suspension single dose intervention 4: 160 mg Piperaquine tablet intervention 5: 480 mg Piperaquine tablet intervention 6: 1440 mg Piperaquine tablet intervention 7: 800mg OZ439 oral suspension single dose

Protocol document: