Overview

Safety, Tolerability & Pharmacokinetics (PK) of Co-administered Single Doses of OZ439 and Mefloquine (MQ) in Healthy Volunteers

Status:
Terminated

Trial end date:
2013-04-01

Target enrollment:

Participant gender:

Summary

OZ439 is a novel, synthetic trioxolane medicine which is related to artemisinin, but has the advantage of a longer elimination half-life so is being developed to be administered together with a potential partner drug e.g. mefloquine as a single dose cure for uncomplicated malaria. The study findings will be used to inform the dose and design of future studies. The aim of the study is to establish the safety, tolerability and pharmacokinetics of co-administered OZ439 and MQ at a range of doses up to the maximum tolerated dose, in healthy volunteers.

Phase:

Phase 1

Details

Lead Sponsor:

Medicines for Malaria Venture

Collaborator:

University of Cape Town

Treatments:

Artefenomel
Mefloquine