CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 55 enrolled
Drug / intervention
1440mg PQP tablets +3 moredrug
Likely dose
1440mg PQP tabletsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01958619
NCT01958619Phase 1Completed
CompareCT.gov

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

Medicines for Malaria Venture·interventional·Posted Oct 9, 2013·Updated May 8, 2015

In Brief

A Phase 1 clinical trial evaluating 1440mg PQP tablets, 960mg PQP tablets, and 2 other interventions for Malaria. Completed, enrolled 55 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesUnited Kingdom
CollaboratorsRichmond Pharmacology Limited

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 9, 2013
Enrollment StartOct 1, 2013
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 12.7 years ago

Interventions

1440mg PQP tabletsdrug

Piperaquine phosphate tablets (1440mg)

960mg PQP tabletsdrug

Piperaquine phosphate tablets (960mg)

800mg OZ439 + TPGSdrug

OZ439 (800mg) + TPGS granules for oral suspension

960mg PQP granulesdrug

Piperaquine phosphate granules for oral solution (960mg)