At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open Label, Parallel Group Study to Investigate the Pharmacokinetics (PK) Following Oral Co-administration of Piperaquine Phosphate (PQP) Tablets With a Prototype OZ439 + TPGS Formulation in the Fasted State in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating PQP tablets 960mg, PQP tablets 1440mg, and 2 other interventions for Malaria. Completed, enrolled 24 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Piperaquine phosphate tablets 960mg
Piperaquine phosphate tablets 1440mg
OZ439+TPGS prototype formulation 800mg
OZ439 Powder in Bottle Aqueous Solution 800mg