Single and Repeated Dose Escalation Study of GSK2838232
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
GSK2838232 is a Human Immunodeficiency Virus (HIV) maturation inhibitor being developed for
the treatment of HIV in combination with other antiretroviral therapy (ART). The primary
objectives of this study are to investigate the safety, tolerability, and pharmacokinetics
(PK) of single and repeat doses of GSK2838232. This study will be a double-blind,
placebo-controlled, single and repeat dose escalation study. This study will be conducted in
two Parts: single escalating doses (Part 1A and 1B), and repeated escalating once daily (QD)
doses for 11 days (Part 2) of GSK2838232 co-dosed with RTV. During Part 1A, single doses of
GSK2838232 (as of active pharmaceutical ingredient-powder in bottle [API PiB]) 50 milligrams
(mg), 100mg and 200mg will be administered with RTV. Part 1B will evaluate the relative
bioavailability of single doses of crystalline active pharmaceutical ingredient (API)
Immediate Release Tablet (IR) tablets versus API PiB as reference, administered with RTV. In
Part 2, multiple doses of GSK2838232 will be co-administered with RTV 100mg QD for 11 days as
sequential dose cohorts. Maximum duration of study participation will be approximately 10
weeks.