

Up to 18 subjects will be enrolled into Part A and up to 40 subjects will be enrolled into Part B.

Dividing the total daily dose into 2 or 3 smaller doses may be done in both Part A and Part B.

Appropriate doses and dose regimens for Part B will be selected based on available safety, tolerability and PK data from Part A and/or any preceding repeat dose cohorts from Part B. Part B will comprise up to 4 cohorts (Cohorts 3, 4, 5, and 6) each containing 10 (8 active: 2 placebo) healthy adult subjects to examine the safety, tolerability and PK of a repeated daily dose of GSK3036656 over a period of up to 14 days. Study progression to Part B from Part A will be based on an acceptable safety, tolerability and PK profile in Part A. Initially, there will be a 14 day wash out period for individual subjects between each dose level. The two cohorts in Part A will be dosed sequentially (i.e., dosing in Cohort 2 starts after dosing in Cohort 1 is completed). The starting dose in Part A will be 5 milligrams (mg), and the maximum dose will be 1500 mg. During each treatment period, GSK3036656 will be administered to 6 subjects and placebo will be administered to 3 subjects. Each cohort will participate in up to 4 treatment (dosing) periods including a food effect treatment period.

9 healthy adult subjects will be included in each cohort. Up to two cohorts will be included in Part A. The study will be conducted in two parts: Part A (single dose) and Part B (repeat dose). A food effect assessment will also be undertaken to investigate the influence of food on the PK of GSK3036656. The results of this study are intended to be used to identify appropriate and well-tolerated doses of GSK3036656 to be used in further studies. This is the FTIH study for GSK3036656 to evaluate the safety, tolerability and PK of single ascending and repeat oral doses of GSK3036656 in healthy adult subjects. GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). Why Should I Register and Submit Results?.
