CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 59 enrolled
Drug / intervention
100mg OZ439 single oral dose +6 moredrug
Likely dose
100mg OZ439 single oral dosefrom 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/NCT01660022
NCT01660022Phase 1Completed
CompareCT.gov

A Phase I Study to Investigate the Safety, Tolerability & Pharmacokinetics of Co-administered Single Doses of OZ439 and Piperaquine to Healthy Subjects

Medicines for Malaria Venture·interventional·Posted Aug 8, 2012·Updated Jan 21, 2015

In Brief

A Phase 1 clinical trial evaluating 100mg OZ439 single oral dose, Placebo, and 5 other interventions for Healthy. Completed, enrolled 59 participants across 1 site.

Detailed Summary

A Phase I Study to investigate the safety, tolerability \& pharmacokinetics of co-administered single doses of OZ439 and Piperaquine to healthy subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSwitzerland
CollaboratorsCross Research S.A.

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 8, 2012
Enrollment StartSep 1, 2012
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.9 years ago

Interventions

100mg OZ439 single oral dosedrug

100mg OZ439 oral suspension single dose

Placebodrug

Placebo

300 mg OZ439 single oral dosedrug

300mg OZ439 oral suspension single dose

160mg Piperaquine single oral dosedrug

160 mg Piperaquine tablet

480mg Piperaquine single oral dosedrug

480 mg Piperaquine tablet

1440mg Piperaquine single oral dosedrug

1440 mg Piperaquine tablet

800 mg OZ439 single oral dosedrug

800mg OZ439 oral suspension single dose