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

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

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

Sponsors & Collaborators

• Medicines for Malaria Venture

  lead OTHER

Principal Investigators

• Joerg Moehrle, PhD · Medicines for Malaria Venture

• Maria Gutierrez, MD · Comprehensive Phase One Miramar, 3400 Enterprise Way, Miramar, FL 33025

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-04-30

Primary Completion

2009-10-31

Completion

2009-12-31

Countries

• United States

Study Locations