Overview

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

Status:
Completed
Trial end date:
2017-05-30
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Medicines for Malaria Venture
Treatments:
Artefenomel
Cobicistat
Cytochrome P-450 CYP3A Inhibitors