PK of MMV390048 in healthy volunteers
Research type
Research Study
Full title
A Phase 1 exploratory study to evaluate the pharmacokinetics of selected oral formulations of MMV390048 administered in the fasted state to healthy volunteers
IRAS ID
183590
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Medicines for Malaria Venture
Eudract number
2015-003313-18
Research summary
We are conducting a clinical trial with an investigational medication known as MMV390048 which is being developed for the treatment of malaria; for which there is no effective treatment. In the last few decades the malaria parasite has developed resistance to the drugs available to treat malaria leading to a revival of the disease.
MMV390048 has the potential to treat malaria with a single therapeutic dose. However, the current MMV390048 formulation of Powder in Bottle (PIB) appears to lead to different results between volunteers in the previous First Time in Human (FTIH) study conducted in healthy volunteers.
The purpose of this study is to identify a suitable formulation of MMV390048, from two new prototype formulations, when administered in 2 cohorts as a single 40 mg dose in order to accurately predict which formulation can be used to treat malaria effectively using one single dose. MMV390048 will be administered to up to 18 healthy volunteers in the fasted state. MMV390048 levels will be measured in the blood after dosing (pharmacokinetics) and we will assess the safety of MMV390048 and how well the different formulations are tolerated.
An optional cohort may be enrolled according to the adaptive features of the study. In this cohort up to 9 volunteers will be given MMV390048 with milk or in the fed state.
The time commitment required from each volunteer is approximately 58 days and the study will be conducted at Richmond Pharmacology Ltd. The study is funded by Medicines for Malaria Venture (the sponsor), which is a not-for-profit organization based in Geneva, Switzerland.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/1415
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion