Study to Evaluate the Effect of GSK3640254 on the Pharmacokinetics of Tenofovir Alafenamide/Emtricitabine
Status:
Completed
Trial end date:
2019-04-30
Target enrollment:
Participant gender:
Summary
Human immunodeficiency virus (HIV) infection frequently involves combination drug therapy for
its treatment; hence, it is important to understand their interactions and resulting changes
in exposure which are associated with medications. This is a Phase-1, open-label,
fixed-sequence 2-period, one-way drug interaction study to assess the pharmacokinetic (PK),
safety, and tolerability of GSK3640254 and Tenofovir alafenamide/emtricitabine (TAF/FTC) when
administered alone and in combination in healthy subjects. The study will consist of a
screening period of 28 days before the first dose of study intervention followed by 2
sequential treatment periods. Subjects will be administered TAF/FTC 25/200 milligram (mg)
once daily (QD) on Days 1 to 14 of Period 1 followed by co-administration of TAF/FTC 25/200
mg QD with GSK3640254 200 mg QD on Days 1 to 7 of Period 2.