NCT01615822

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

A Phase I Healthy Volunteer Study Investigating the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Mefloquine

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	OZ439 100mg	OZ439 100mg oral suspension, single dose
DRUG	OZ439 400mg	OZ439 400mg oral suspension, single dose
DRUG	MQ 250 mg, single dose	Mefloquine 250 mg tablet, single dose
DRUG	MQ 750mg, single dose	Mefloquine 750mg oral tablet, single dose
DRUG	Placebo

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2012-06-11
• Last updated: 2015-04-16
• Results posted: 2015-03-26

Locations

1 site across 1 country: South Africa