NCT01958619

Open Label Pharmacokinetic Study of OZ439 and Piperaquine on Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in Healthy Volunteers

Open Label Pharmacokinetic Study of OZ439 and Piperaquine Following Administration of OZ439+TPGS Granules for Oral Suspension Alone or With Either Piperaquine Phosphate Tablets or Granules for Oral Solution in the Fasted State in Healthy Volunteers

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

Summary

A healthy volunteer study to characterise the exposure of the two study medications, following administration of OZ439 + TPGS granules with piperaquine phosphate granules (intended for children) and with piperaquine phosphate tablets (intended for adults). Ideally, to confirm the exposure demonstrated in an earlier bioavailability study.

Detailed description

A Phase 1 open label parallel group, four arm study conducted in healthy male and female subject aged 18 to 55 years of age. Subjects will receive either treatment A, B, C or D as described below: * Treatment A: 1440 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension * Treatment B: 960 mg PQP tablets and 800 mg OZ439 + TPGS granules for oral suspension * Treatment C: 960 mg PQP granules for oral solution and 800 mg OZ439 + TPGS granules for oral suspension * Treatment D: 800 mg OZ439 + TPGS granules for oral suspension

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	1440mg PQP tablets	Piperaquine phosphate tablets (1440mg)
DRUG	960mg PQP tablets	Piperaquine phosphate tablets (960mg)
DRUG	800mg OZ439 + TPGS	OZ439 (800mg) + TPGS granules for oral suspension
DRUG	960mg PQP granules	Piperaquine phosphate granules for oral solution (960mg)

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2013-10-09
• Last updated: 2015-05-08
• Results posted: 2015-04-21

Locations

1 site across 1 country: United Kingdom