First Time in human study of RIP1K inhibitor (GSK2982772)
Research type
Research Study
Full title
A single-centre, randomized, double-blind (sponsor unblinded), placebo-controlled two-part study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GSK2982772, in single (in both fed and fasted states) and repeat oral doses in healthy male subjects
IRAS ID
162480
Contact name
Sujith Madhavan
Contact email
Eudract number
2014-001776-66
Duration of Study in the UK
0 years, 11 months, 14 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine (GSK2982772) as a potential medicine in inflammatory conditions for example Crohn’s disease (a type of inflammatory bowel disease), Psoriasis, (an inflammatory itchy skin condition) and Rheumatoid Arthritis (a disease causing painful inflamed joints). GSK2982772 turns off a protein in the body called receptor-interacting protein-1(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.
This is the first research study in which GSK2982772 will be given to humans. The study will look at potential side effects of different doses of GSK2982772, how long the body takes to get rid of it and how the medicine works in the body.
Approximately 52 healthy volunteers will participate in the study comparing GSK2982772 and a placebo (which is a dummy medicine containing no active ingredients). The study will have two parts, Part A (2 groups of 8 volunteers) and Part B (3 groups of 12 volunteers).
Each volunteer will attend a screening visit, in-patient (resident in Clinical Unit Cambridge) treatments visits (Part A: up to 5 visits of 3 and a half days; Part B: 1 visit of 17 days) and one follow up visit. In Part A, during each in-patient treatment visit each volunteer will receive one dose of the study medication (GSK2982772 or placebo). They will receive up to 4 different strengths of study medication and 1 placebo dose during the study. In Part B, each volunteer will receive the same dose of the study medication (GSK2982772 or placebo) each day for 14 days.
Taking part in the study will not have direct benefit to volunteers. The study is sponsored by GlaxoSmithKline and will be conducted in a MHRA accredited clinical research unit in the UK, with adequate safety and compliance facilities.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
14/EE/1209
Date of REC Opinion
3 Dec 2014
REC opinion
Further Information Favourable Opinion