drugset / Trial / NCT04069221

Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study

NCT04069221

Phase 1 Completed 26 enrolled Medicines for Malaria Venture
RandomizedCrossoverOpen-labelTreatment

Summary

This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous \[14C\]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a strong CYP3A4 inhibitor, to healthy subjects in fasted state.

Timeline

Start
2017-02-28
Primary completion
2017-05-30
Completion
2017-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Artefenomel Small molecule 100 ug Oral
Subject Artefenomel Small molecule 400 mg Oral
Subject Artefenomel Small molecule 800 mg Oral
Subject Cobicistat Small molecule 150 mg Oral

Indications