CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 24 enrolled
Drug / intervention
MMV390048 40 mg +5 moredrug
Likely dose
MMV390048 40 mgfrom 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/NCT02783820
NCT02783820Phase 1Completed
CompareCT.gov

A Single Centre, Two-part, Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Ascending Oral Doses of MMV390048 and Its Antimalarial Activity Against Plasmodium Falciparum in Healthy Adult Subjects

Medicines for Malaria Venture·interventional·Posted May 26, 2016·Updated Jun 11, 2020

In Brief

A Phase 1 clinical trial evaluating MMV390048 40 mg, Placebo to match MMV390048 40 mg, and 4 other interventions for Malaria. Completed, enrolled 24 participants across 1 site.

Detailed Summary

This Phase I study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single doses of reformulated MMV390048 when administered to healthy men and women of non-childbearing potential (WNCBP) under fasted conditions (Part A).

Study Details

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

Timeline

Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 26, 2016
Enrollment StartMay 1, 2016
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.1 years ago

Interventions

MMV390048 40 mgdrug

Placebo to match MMV390048 40 mgdrug

MMV390048 80 mgdrug

Placebo to match MMV390048 80 mgdrug

MMV390048 120 mgdrug

Placebo to match MMV390048 120 mgdrug