CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 26 enrolled
Drug / intervention
Single oral dose of 800 mg OZ439 +3 moredrug
Likely dose
Single oral dose of 800 mg OZ439from 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/NCT04069221
NCT04069221Phase 1Completed
CompareCT.gov

An Open-label, Two-part Study to Determine the Absolute Bioavailability (BA) of OZ439 Using Simultaneous Intravenous [14C]-OZ439 Microdose/800mg Oral Dosing and to Investigate the Pharmacokinetics (PK) of OZ439 Granules Administered as Single Doses Suspended in Different Volumes and When Co-administered With a Single Dose of Cobicistat, a Strong CYP3A4 Inhibitor, to Healthy Subjects in Fasted State

Medicines for Malaria Venture·interventional·Posted Aug 28, 2019·Updated Nov 26, 2019

In Brief

A Phase 1 clinical trial evaluating Single oral dose of 800 mg OZ439, Single oral dose of 400 mg OZ439, and 2 other interventions for Malaria. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This study is an open-label, two-part study to determine the absolute bioavailability (BA) of OZ439 using simultaneous intravenous \[14C\]-OZ439 microdose/800mg oral dosing and to investigate the pharmacokinetics (PK) of OZ439 granules administered as single doses suspended in different volumes and when co-administered with a single dose of Cobicistat, a strong CYP3A4 inhibitor, to healthy subjects in fasted state.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalaria
CountriesNetherlands
Collaborators--

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 28, 2019
Enrollment StartFeb 28, 2017
Primary CompletionMay 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.8 years ago

Interventions

Single oral dose of 800 mg OZ439drug

Single oral dose of 800 mg OZ439

Single oral dose of 400 mg OZ439drug

Single oral dose of 400 mg OZ439

Single oral dose of cobicistatdrug

Single oral dose of 150 mg cobicistat

iv infusion of [14C]-OZ439drug

15-minute 10-mL iv infusion of 100 μg \[14C\]-OZ439