NCT02230579

Phase I Study of Ascending Doses of MMV390048 in Healthy Adult Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Medicines for Malaria Venture · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is a single centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy male and female volunteers (of non-childbearing potential) aged 18 to 55 years. The study will be divided into two parts. The first part will comprise up to seven fasted cohorts (8 to 10 volunteers in each) that will receive a single, ascending dose (SAD) of MMV390048 to assess its safety, tolerability and pharmacokinetic profile. The starting dose administered to the first cohort will be 5 mg. An additional cohort (cohort 8, re-using volunteers from one of the previous cohorts) will receive a single dose of MMV390048 in a fed state to evaluate the effect of food on the pharmacokinetics and tolerability of the compound. The data obtained from each cohort during the SAD part of the study will undergo a formal review by the Safety Review Team (SRT). Should the safety profile of the compound be deemed acceptable, and the pharmacokinetic parameters indicate that acceptable levels of the drug to elicit a pharmacodynamic response can be achieved in human plasma, the study will then proceed to the second part. During the second part of the study volunteers will receive multiple, ascending doses (MAD) of MMV390048 to assess the pharmacokinetics, safety and tolerability following multiple oral doses. Up to three cohorts of eight volunteers each will be enrolled into this part of the study. Each volunteer will receive three consecutive daily doses of MMV390048.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	MMV390048 5mg	Supplied as "powder in bottle" formulation for reconstitution pre-dose
DRUG	MMV390048 20mg	Supplied as "powder in bottle" formulation for reconstitution pre-dose.
DRUG	MMV390048 40mg	Supplied as "powder in bottle" formulation for reconstitution pre-dose
DRUG	MMV390048 80mg	Supplied as "powder in bottle" formulation for reconstitution pre-dose
DRUG	MMV390048 120mg	Supplied as "powder in bottle" formulation for reconstitution pre-dose
DRUG	Placebo to match MMV390048	Supplied as "powder in bottle" formulation for reconstitution pre-dose

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-09-03
• Last updated: 2019-07-17
• Results posted: 2018-10-29

Locations

1 site across 1 country: South Africa