High Dose GSK2982772 Safety and PK Study in Healthy Volunteers.
Research type
Research Study
Full title
A single-centre, randomized, double-blind (sponsor-unblinded), placebo-controlled study to evaluate the safety, tolerability and pharmacokinetics of GSK2982772, in repeat oral doses in healthy subjects
IRAS ID
232275
Contact name
Michalis Kostapanos
Contact email
Sponsor organisation
GlaxoSmithLine
Eudract number
2017-002662-45
Duration of Study in the UK
0 years, 10 months, 6 days
Research summary
GlaxoSmithKline (GSK) is developing a new drug (GSK2982772) for the treatment of inflammatory conditions, such as ulcerative colitis (inflammatory bowel disease), psoriasis (inflammatory skin condition) and rheumatoid arthritis (disease causing painful inflamed joints). GSK2982772 turns off a protein in the body called receptor interacting protein1 (RIP1) kinase. This protein controls how the cells in the body talk to each other when they are inflamed. Turning off this protein with GSK2982772 might reduce inflammation in the body.
GSK2982772 was used in a previous trial for first time in human. New data from animal studies showed that higher doses than the ones used before could be employed. The aim of this study is to test the safety and tolerability of GSK2982772, and its blood levels at higher doses to support dose selection in future patient studies. The study will also determine the effect of food on GSK2982772 absorption and whether GSK2982772 has the potential to affect the capacity of the liver to breakdown other drugs (Part B only).
Up to 48 healthy male and female volunteers will be randomly allocated to receive either GSK2982772 or placebo, given as an oral capsule either three times a day or twice a day. This study will test 3 different strengths of GSK2982772 as single and repeat doses, and will be conducted in 2 parts:
•Part A: 12 volunteers will receive 3 single-day doses of GSK2982772 or placebo at three different inpatient visits.
•Part B: 36 volunteers will receive repeated doses of GSK2982772 or placebo for 14 days.Taking part in the study will not have a direct benefit to participants. The study is sponsored by GSK, and will be conducted in a Medicines and Health Care Products Regulatory Agency (MHRA) accredited clinical research unit in the United Kingdom, with adequate safety and compliance facilities.
REC name
HSC REC B
REC reference
17/NI/0167
Date of REC Opinion
13 Sep 2017
REC opinion
Favourable Opinion