GSK3640254 FTIH study in healthy participants
Research type
Research Study
Full title
A Double-Blind (Sponsor Unblinded), Randomized, Placebo-Controlled, Single and Repeated Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK3640254 in Healthy participants
IRAS ID
227663
Contact name
Disala Fernando
Contact email
Sponsor organisation
GSK, R&D Projects Clinical Platforms and Sciences
Eudract number
2017-001367-21
Duration of Study in the UK
0 years, 11 months, 9 days
Research summary
Human Immunodeficiency Virus-1 (HIV-1) is a serious health threat with more than 40 million people infected worldwide.
The long-term side effects associated with current drug treatments for HIV-1 and the emergence of drug resistant forms of the virus have presented a need for new therapies. Therefore, ViiV Healthcare is developing a new medicine (GSK3640254) for treatment of HIV-1 infection. GSK3640254 works by preventing maturation HIV-1 in the body. This is the first time that GSK3640254 will be given to humans. The primary aims of the study are to assess the safety, tolerability and blood levels of the drug when given in single and multiple doses following a meal. The study will also investigate how the body deals with the drug.
The study will be conducted in healthy volunteers in two parts. Both parts will have a screening period of 28 days. In part 1, two groups of 8 volunteers (16 total) will receive up to 4 increasing single doses of either GSK3640254 or Placebo each at 4 different periods. Eight volunteers may receive GSK3640254 without food to look at the effect of food on drug levels in the blood. In part 2, four groups of 8 volunteers will receive repeated doses of either GSK3640254 or Placebo for 14 days and an additional group of 24 volunteers will receive repeated doses of either GSK3640254 or Placebo for 14 days to look at gastrointestinal effects (56 volunteers in total). A further follow-up visit will be done 7 – 14 days after the last dose in both parts.
Taking part in the study will not have a direct benefit to volunteers. The study is sponsored by ViiV Healthcare, and will be conducted in a MHRA accredited GSK Clinical Unit in Cambridge UK, with adequate safety and compliance facilities.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0298
Date of REC Opinion
24 Jul 2017
REC opinion
Further Information Favourable Opinion