Healthy Volunteers Clinical Trial
Official title:
A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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