drugset / Trial / NCT01383096
Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers
Phase 1
Completed
52 enrolled
Medicines for Malaria Venture
Nucleus Network Ltd · collabSyneos Health · collab
RandomizedCrossoverOpen-labelTreatment
Summary
This study is designed to assess prototype formulations compared to the aqueous dispersion of Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that observed when given after food. This will improve the utility of OZ439 in the field as well as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very important for an antimalarial drug product destined for use in developing counties.
Timeline
- Start
- 2012-04
- Primary completion
- 2012-08
- Completion
- 2012-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artefenomel | Small molecule | 400 mg | Oral |
| Subject | Artefenomel | Small molecule | 800 mg | Oral |
Indications
No indication recorded.