A study to investigate the safety and pharmacokinetics of GSK4024484 in healthy adult participants
Research type
Research Study
Full title
A randomised, double blind placebo-controlled, first time in human study to evaluate the safety and pharmacokinetics of single and multiple oral doses and food effect of GSK4024484 in healthy adult participants.
IRAS ID
1008768
Contact name
Tania Mateus
Contact email
Sponsor organisation
GSK Research & Development Limited
Research summary
Malaria is an infection that is spread by mosquito bites and caused by a parasite that lives in the mosquito. This results in an illness with a high fever that affects multiple parts of the body.
A recent estimate is that there were 247 million malaria cases and 619 000 deaths in 2021, with 76% of the deaths being in children under five.
Of the malaria parasites, Plasmodium (P.) falciparum is the deadliest and P. vivax is the most common.
There are treatments available for malaria. However, there is increasing resistance of Plasmodium parasites to these medicines. Resistance means the parasites develop the ability to defeat the medications. Therefore, there is a need for new treatments.
GSK is developing a drug (GSK4024484), that has been shown in the laboratory to be quick at killing P. falciparum parasites. It can also kill P. vivax. GSK4024484 works in a different way to the current treatments and is being developed to be used as a curative treatment for uncomplicated P. falciparum in adults and children in combination with other medicines.
This is the first time that GSK4024484 will be tested in humans. So far, it has only been tested in animals and in the laboratory. We are doing this to answer the following questions:
• Does the study drug have any important side effects and is it safe and well-tolerated?
• How does the body handle the study drug and how long does the body take to remove it from the blood stream (pharmacokinetics)?
• Does food affect the absorption of the study drug into the bloodstream?
Participants can be male, or female who are no longer able to have children, and 18 to 60 years old. In Part A, participants will receive a single ascending dose of study treatment. About 96 participants, up to a maximum of 108 participants, will take part. In Part B, participants will receive a multiple ascending dose and about 36 participants will take part.
The total duration for each participant is approximately 12 weeks.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
23/EE/0235
Date of REC Opinion
14 Nov 2023
REC opinion
Further Information Favourable Opinion