NCT00928083

A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects

A Phase I Study To Investigate The Safety, Tolerability And Pharmacokinetic Profile Of OZ439 In Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria Falciparum
• Malaria Vivax
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	OZ439 50mg API capsules
DRUG	OZ439 200mg API capsules
DRUG	OZ439 400mg aqueous dispersion
DRUG	OZ439 800mg aqueous dispersion
DRUG	OZ439 100mg API capsules	OZ439 100mg (2x50mg API capsules)
DRUG	OZ439 400mg API capsules	OZ439 400mg (2x200mg API capsules)
DRUG	OZ439 1600mg aqueous dispersion
DRUG	OZ439 800mg API capsules	OZ439 800mg (4x200 API capsules)
DRUG	OZ439 1200mg API capsules	OZ439 1200mg (6x200mg API capsules)
DRUG	Placebo
DRUG	OZ439 200mg aqueous dispersion

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• Completion: 2009-12-01
• First posted: 2009-06-25
• Last updated: 2015-01-08
• Results posted: 2015-01-08

Locations

1 site across 1 country: United States