CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
480 mg Piperaquine phosphate +6 moredrug
Likely dose
480 mg Piperaquine phosphatefrom 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/NCT03542149
NCT03542149Phase 1Completed
CompareCT.gov

Phase 1b to Assess Safety, Tolerability, Pharmacokinetic Profile, and Antimalarial Activity of Single Doses of Co-administered OZ439and PQP Against Early Plasmodium Falciparum Blood Stage Infection in Healthy Adult Volunteers

Medicines for Malaria Venture·interventional·Posted May 31, 2018·Updated May 10, 2024

In Brief

A Phase 1 clinical trial evaluating 480 mg Piperaquine phosphate, 640 mg Piperaquine phosphate, and 5 other interventions for Malaria. Completed, enrolled 24 participants across 1 site.

Detailed Summary

A single-centre Phase 1b study to assess the safety, tolerability, pharmacokinetic profile, and antimalarial activity of single doses of coadministered artefenomel (OZ439) and piperaquine phosphate (PQP) against early Plasmodium falciparum blood stage infection in healthy adult volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesAustralia
CollaboratorsQIMR Berghofer Medical Research Institute, Clinical Network Services (CNS) Pty Ltd, Q-Pharm Pty Limited

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedMay 31, 2018
Enrollment StartApr 23, 2018
Primary CompletionApr 19, 2019
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 8.1 years ago

Interventions

480 mg Piperaquine phosphatedrug

480 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

640 mg Piperaquine phosphatedrug

640 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

200 mg OZ 439drug

200 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

400 mg OZ 439drug

400 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

800 mg OZ 439drug

800 mg OZ439 + α-tocopherol polyethylene glycol 1000 succinate (TPGS) granules for oral suspension

960 mg PQPdrug

960 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.

320 mg PQPdrug

320 mg Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.