At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 48 enrolled

Drug / intervention

MMV390048 5mg +5 moredrug

Likely dose

MMV390048 5mgfrom 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/NCT02230579

NCT02230579Phase 1Completed

Compare CT.gov

A Single Centre, Two-part, Double-blind, Randomized, Placebo-controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of Ascending Doses of MMV390048 in Healthy Adult Volunteers

Medicines for Malaria Venture·interventional·Posted Sep 3, 2014·Updated Jul 17, 2019

In Brief

A Phase 1 clinical trial evaluating MMV390048 5mg, MMV390048 20mg, and 4 other interventions for Malaria. Completed, enrolled 48 participants across 1 site.

Detailed Summary

This is a first-in-human study of MMV390048. The study will evaluate the safety, tolerability and pharmacokinetic properties of escalating single and multiple doses of MMV390048 when administered to healthy male volunteers and female volunteers of non-childbearing potential. In addition, the effect of food on the pharmacokinetics and tolerability of MMV390048 will be investigated.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMalaria

CountriesSouth Africa

CollaboratorsUniversity of Cape Town

Timeline

Phase 1CompletedFinished

2014201520162017201820192020202120222023202420252026

Enrollment StartMay 2014

First PostedSep 2014

Primary CompletionFeb 2015

TodayJul 2026

First PostedSep 3, 2014

Enrollment StartMay 1, 2014

Primary CompletionFeb 1, 2015

TodayJul 2, 2026

Enrollment to primary: 9 monthsPosted 11.8 years ago