drugset / Trial / NCT01615822

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

NCT01615822

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2012-08
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Artefenomel Small molecule 100 mg Oral
Subject Artefenomel Small molecule 400 mg Oral
Subject Mefloquine Unknown 250 mg Oral
Subject Mefloquine Unknown 750 mg Oral

Indications