Healthy Volunteer Study of the Pharmacokinetics of Oral Piperaquine With OZ439 + TPGS Formulation in the Fasted State
Status:
Completed
Trial end date:
2013-07-01
Target enrollment:
Participant gender:
Summary
Piperaquine tablets (coated) + OZ439 granules + TPGS granules will be co-administered in
Phase IIb (adults). However, safety and PK data (for OZ439 plus piperaquine) were obtained
using piperaquine tablets plus OZ439 as Powder in Bottle with milk. Piperaquine has not yet
been administered together with TPGS. Co-administration of piperaquine plus OZ439 as Powder
in Bottle (PIB) with milk results in an increase in OZ439 exposure (current estimate ~ 70%
due to a small drug drug interaction).
This study investigates the exposure of piperaquine and OZ439 when co-administered as
piperaquine phosphate tablets and OZ439 + TPGS prototype (a formulation close to that of
Phase IIb, but not identical), in order to select the appropriate doses for Phase IIb. The
reference treatment is piperaquine phosphate tablets + OZ439 Powder in Bottle + full fat milk