Bioavailability Study of Two Salt Formulations of GSK3640254
Research type
Research Study
Full title
A single centre, 2-period, randomized, open-label Phase 1 study to assess the relative bioavailability of a mesylate salt capsule of GSK3640254 compared to a hydrochloride salt capsule in healthy participants
IRAS ID
244061
Contact name
Riya Moodley
Contact email
Sponsor organisation
Viiv Healthcare UK Limited
Eudract number
2018-001175-21
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
The Sponsor is developing the test medicine, GSK3640254, for the potential treatment of Human Immunodeficiency Virus-1 (HIV-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 the treatment of HIV-1 infection. GSK3640254 works by preventing the advancement of HIV-1 in the body.The purpose of the study is to compare how 2 different salt formulations (recipes) of the test medicine are taken up by the body.
The study will consist of 2 study periods involving up to 14 healthy male and female volunteers. In each period, all volunteers will receive one of 2 regimens. During regimen A the volunteers will receive 200 mg of the hydrochloride salt formulation of the test medicine, and during regimen B the volunteers will receive 200 mg of the mesylate salt formulation of the test medicine. Both of the formulations will be given by mouth and the order that the volunteers receive the regimens will be randomised.
REC name
Wales REC 2
REC reference
18/WA/0144
Date of REC Opinion
7 Jun 2018
REC opinion
Further Information Favourable Opinion