PK of Modified Release formulations of GSK2982772 (QCL117918)
Research type
Research Study
Full title
A two part, non-randomised, open label study designed to assess the pharmacokinetics of GSK2982772 following administration of modified release formulations in capsule relative to an immediate release reference tablet formulation (Part A) and the pharmacokinetics of escalating, repeat doses of a selected modified release prototype (Part B) in healthy subjects
IRAS ID
229633
Contact name
Dipak Kothari
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2017-000652-25
Duration of Study in the UK
0 years, 4 months, 13 days
Research summary
The sponsor GlaxoSmithKline Research & Development Limited (also known as GSK) are developing a new formulation (recipe) of the test medicine GSK2982772, for the potential treatment of diseases caused by inflammation such as inflammatory bowel disease (IBD), plaque psoriasis (PsO), rheumatoid arthritis (RA).
The study will try to identify a new formulation of the test medicine which allows for more convenient once daily dosing for patients.
The study will consist of 2 parts. Part A is a 6 period cross-over in 16 healthy volunteers, designed to evaluate up to 4 formulations following single 120 mg doses in the fasted state. This part may also investigate the effect of food on a selected formulation, and there is also the option to cancel Periods 5 and 6 if favourable formulation is determined in Periods 1 or 2. Part B is a 3 period cross-over in 10 healthy volunteers designed to evaluate 3 days of repeat dosing of a selected formulation of the test medicine at target daily doses of 30, 60 and 240 mg given either once or twice day.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0404
Date of REC Opinion
5 Sep 2017
REC opinion
Further Information Favourable Opinion