At a glance
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A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects
In Brief
A Phase 1 clinical trial evaluating OZ439 50mg API capsules, OZ439 200mg API capsules, and 9 other interventions for Malaria Falciparum and 2 related conditions. Completed, enrolled 63 participants across 1 site.
Detailed Summary
OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent. This was a Phase I, single-centre, multi-component, double-blind, randomised, placebo-controlled study in healthy male and female subjects. The study was conducted in 3 parts: * Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose proportionality. * Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way crossover design. * Part C investigated the safety, tolerability and PK profile of multiple oral doses of OZ439. The starting oral dose was 50 mg and the maximum single dose to be administered did not exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.
Study Details
Timeline
Interventions
OZ439 100mg (2x50mg API capsules)
OZ439 400mg (2x200mg API capsules)
OZ439 800mg (4x200 API capsules)
OZ439 1200mg (6x200mg API capsules)