First Time in Human (FTIH) Safety and Pharmacokinetics (PK) Study of GSK3036656 in Healthy Subjects
Status:
Completed
Trial end date:
2017-08-04
Target enrollment:
Participant gender:
Summary
GSK3036656 is being developed by GSK for the treatment of tuberculosis (TB). 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. 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. A food effect assessment will also be undertaken to investigate the
influence of food on the PK of GSK3036656. The study will be conducted in two parts: Part A
(single dose) and Part B (repeat dose). Up to two cohorts will be included in Part A. 9
healthy adult subjects will be included in each cohort. Each cohort will participate in up to
4 treatment (dosing) periods including a food effect treatment period. During each treatment
period, GSK3036656 will be administered to 6 subjects and placebo will be administered to 3
subjects. The starting dose in Part A will be 5 milligrams (mg), and the maximum dose will be
1500 mg. The two cohorts in Part A will be dosed sequentially (i.e., dosing in Cohort 2
starts after dosing in Cohort 1 is completed). Initially, there will be a 14 day wash out
period for individual subjects between each dose level. Study progression to Part B from Part
A will be based on an acceptable safety, tolerability and PK profile in Part A. 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. 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. Dividing the total daily dose into 2 or 3 smaller
doses may be done in both Part A and Part B. Up to 18 subjects will be enrolled into Part A
and up to 40 subjects will be enrolled into Part B. The total duration of the study for each
subject recruited into Part A and Part B will be approximately 12 weeks and 8 weeks,
respectively.