drugset / Trial / NCT01713608

A Dose-escalation Study to Investigate Safety and Toleration of OZ439

NCT01713608

Phase 1 Completed 34 enrolled Medicines for Malaria Venture
RandomizedSingle-groupQuadruple-blindBasic science

Summary

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: * To determine the safety and tolerability of ascending doses of OZ439 OD for three days. * To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. * To identify the maximum tolerated dose of OZ439 administered.

Timeline

Start
2012-11
Primary completion
2013-02
Completion
2013-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Artefenomel Small molecule 300 mg

Indications