Infection, Human Immunodeficiency Virus Clinical Trial
Official title:
A Double-Blind, Randomized, Placebo-Controlled, Continuation Single Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 With and Without Ritonavir, and to Evaluate Different Formulations of GSK2838232, in Healthy Subjects
This study investigates the safety, tolerability and PKs of GSK2838232 with and without
Ritonavir, and to evaluate different formulations of GSK2838232 in healthy subjects. This
study will evaluate higher single and RTV boosted doses to support continued clinical
development of GSK2838232 at clinically relevant doses, and subsequently in those infected
with HIV in a dose ranging phase 2 study. The study is conducted in 2 parts: Part A and Part
B, study Part A and Part B may be conducted in parallel. Approximately 20 healthy subjects
will be enrolled into the study, 8 in Part A and 12 in Part B. Part A is a double-blind,
randomized, placebo-controlled, 4-period, single dose escalation design. Subjects will be
randomized 3:1 to receive GSK2838232 or placebo. Subjects randomized to placebo will receive
placebo in all four periods. Following completion of Period 2 PK assessments at 96hr
post-dose, subjects will begin daily dosing of RTV 100mg for a total of 26 days.
Part B is a randomized, open-label, unbalanced, 3-period, cross-over design; subjects will
be randomized 1:1 to each sequence. The relative bioavailability of single 100mg doses of
powder in a bottle (PIB) active pharmaceutical ingredient (API) of GSK2838232 versus PIB
spray-dried dispersion (SDD) will be assessed. A single dose of GSK2838232 will
co-administered on the 10th day of RTV dosing; RTV dosing will continue for an additional 4
days (total of 14 days). Subjects will have a screening visit within 30 days prior to first
dose and a follow-up visit 7-14 days after the last dose.
n/a
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