SAD/MAD evaluation of BMS-986195 in healthy volunteers (QCL117711)
Research type
Research Study
Full title
A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD), and Non-Randomized, Bioavailability (BA) Study of BMS-986195 in Healthy Subjects
IRAS ID
199582
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2015-004300-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 18 days
Research summary
The Sponsor is developing the study drug, BMS-986195, for the potential treatment of rheumatoid arthritis (RA) and other autoimmune diseases. Symptoms of RA include pain, stiffness and swelling at the joints.\n\nThe study will try to identify the safety and tolerability of single and multiple oral doses of BMS-986195 in healthy subjects. BMS-986195 is a potent, selective, and irreversible, small molecule inhibitor of Bruton’s Tyrosine Kinase (BTK). BTK is central in the activation of the cellular pathway that triggers RA. BMS-986195 is efficacious in preclinical models of rheumatoid arthritis and other autoimmune and inflammatory diseases.\n\nThe study will consist of 4 parts involving up to 118 healthy male and female subjects. In Part A subjects will be randomised in a 3:1 ratio to receive BMS-986195 (N=6) or placebo (N=2) on the first day of one of six dosing periods. In Part B subjects will be randomised in a 3:1 ratio to receive a daily oral administration of BMS-986195 (N=6) or placebo (N=2) in one of four dosing periods each consisting of 14 days. Part C will enrol 8 Japanese subjects who will be randomised in a 3:1 ratio to receive a daily oral administration of BMS-986195 (N=6) or placebo (N=2) in one of three dosing periods each consisting of 14 days. In Part D 14 subjects will receive a single oral dose of BMS-986195 on days 1, 5, 9 and 13 of a 16 day treatment period. On day 1 the study drug will be given as an oral solution under fasted conditions, on day 5 it will be given as an oral solution under fed conditions, on day 9 it will be given as a suspension formulation under fasted conditions and on day 13 will be given as a suspension formulation under fed conditions.
REC name
Wales REC 2
REC reference
16/WA/0089
Date of REC Opinion
7 Apr 2016
REC opinion
Further Information Favourable Opinion