First time in human study of GSK2292767 in healthy volunteers
Research type
Research Study
Full title
A single-centre, single-blind (sponsor open), placebo controlled two part study to evaluate the safety, tolerability and pharmacokinetics of single and repeat doses of GSK2292767 as a dry powder in healthy participants who smoke cigarettes.
IRAS ID
217058
Contact name
Disala Fernando
Contact email
Sponsor organisation
R&D Projects Clinical Platforms and Sciences,GSK
Eudract number
2016-003188-21
Duration of Study in the UK
0 years, 5 months, 27 days
Research summary
GlaxoSmithKline (GSK) is developing a new medicine (GSK2292767) as a potential treatment for respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD, a lung disease in people who smoke tobacco). PI3K delta, a protein present in immune cells of the body is known to contribute to inflammatory reactions in asthma and COPD. Blocking PI3Kdelta by GSK2292767 may dampen these inflammatory reactions which may provide clinical benefit to asthma and COPD patients.
This is the first time GSK2292767 will be given as a dry powder inhaler to human volunteers who smoke tobacco. The study will investigate how well GSK2292767 is tolerated, safety of the drug, how it works in the body and how long the body takes to get rid of it. Investigations will include induction of sputum and bronchoscopy. Knowledge from this study may help doctors better understand COPD treatment.
This study will compare GSK2292767 and placebo (which is a dummy medicine containing no active ingredients) inhalers. The study is divided into Part A (up to 32 volunteers) and Part B (up to 12 volunteers).
There will be a screening visit, an in-patient stay in the Clinical Unit Cambridge, numerous treatment visits, and a follow up visit. Part A has 3 treatment visits and during each 1 day in-patient treatment, volunteers will be randomised to receive one dose of the study medication (GSK2292767 or placebo). They will receive up to 3 different doses of study medication during the study. In Part B, each volunteer will receive same dose of the study medication (GSK2292767 or placebo) for 14 days.
Taking part in the study will not have a direct benefit to volunteers. The study is sponsored by GSK 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
16/EE/0481
Date of REC Opinion
23 Nov 2016
REC opinion
Favourable Opinion