NCT01853475

Healthy Volunteer Study of the Pharmacokinetics of Oral Piperaquine With OZ439 + TPGS Formulation in the Fasted State

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

Objectives: 1. To evaluate the piperaquine and OZ439 pharmacokinetics when administered as a combination of piperaquine phosphate tablets with OZ439 / TPGS formulation in the fasted state 2. To evaluate the piperaquine and OZ439 pharmacokinetics of a reference free combination formulation: piperaquine phosphate tablets with OZ439 powder in bottle (PIB) given with full fat milk 3. To determine safety and tolerability of OZ439 and piperaquine phosphate when co-administered.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	PQP tablets 960mg	Piperaquine phosphate tablets 960mg
DRUG	PQP tablets 1440mg	Piperaquine phosphate tablets 1440mg
DRUG	OZ439+TPGS 800mg	OZ439+TPGS prototype formulation 800mg
DRUG	OZ439 PIB 800mg	OZ439 Powder in Bottle Aqueous Solution 800mg

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2013-05-15
• Last updated: 2015-04-30
• Results posted: 2015-04-08

Locations

1 site across 1 country: United Kingdom