Dataset from A Double-Blind, Randomized, Placebo-Controlled, Single Dose Escalation First Time in Human Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK2838232 and to Evaluate the Effect of Food and Ritonavir on GSK2838232 in Healthy Subjects

GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the treatment of chronic HIV infection. This study is the first administration of GSK2838232 in humans to establish the initial safety, tolerability, and pharmacokinetic profile following single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1, approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose visit. There will be four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four dosing sessions for each subject with subjects randomized to receive placebo in a random sequence.

GSK2838232是一种新型人类免疫病毒（HIV）成熟抑制剂，目前正被开发用于慢性HIV感染的治疗。本研究为GSK2838232首次人体给药试验，旨在明确单剂量给药后的初步安全性、耐受性及药代动力学特征，并评估健康受试者中食物与利托那韦（ritonavir，RTV）对GSK2838232的影响。
本研究共设2个队列。队列1中，每个剂量给药访视将纳入约8名健康受试者（6名活性药物组，2名安慰剂组），每位受试者将接受4次给药疗程，且将以随机顺序被分配接受安慰剂。
队列2中，每个剂量给药访视将纳入约8名健康受试者（6名活性药物组，2名安慰剂组），每位受试者将接受4次给药疗程，且将以随机顺序被分配接受安慰剂。