drugset / Trial / NCT04069221
Absolute BA and OZ439 PK Effect of Different OZ439 Dose Volumes and Cobicistat Co-administration Study
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |