First Time in Human Study of the TRPV4 blocker GSK2798745
Research type
Research Study
Full title
A sponsor un-blinded, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and repeat, ascending doses of GSK2798745 in healthy subjects and stable heart failure patients
IRAS ID
142101
Contact name
Joseph Cheriyan
Contact email
Sponsor organisation
GlaxoSmithKline R&D
Eudract number
2013-004547-23
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
GlaxoSmithKline (GSK) is developing a new drug, GSK2798745, which blocks the activity of a protein in the blood vessels of the lungs, called TRPV4. In animals, blocking TRPV4 helped control the accumulation of fluid in the lungs. This means that GSK2798745 may potentially reduce fluid accumulation in the lungs and the symptoms of difficulty in breathing in patients with heart failure.
By comparing GSK2798745 and a placebo (dummy drug without active ingredient), the study will test the safety and tolerability of GSK2798745 given as a liquid and capsule, how long it takes to clear the drug from the body, and the effects on exercise ability and lung function (for example, diffusion capacity) before and after exercise. This study is the first time GSK2798745 will be given to humans, with approximately 36 healthy volunteers and 15 patient-volunteers who have heart failure, participating in this study.
Design: Part 1: increasing single oral doses from 0.25 mg to 4mg of GSK2798745 or placebo; Part 2: comparisons of GSK2798745 given as a liquid or capsule and the effects of taking it with food; Part 3: repeated dosing with GSK2798745 or placebo either once or twice daily for 14 days to determine whether lung function both before and after exercise is changed. Part 4: single and repeat doses of GSK2798745 or placebo, testing similar effects in patients with stable heart failure.
Study duration (including screening): Part 1: up to 17 weeks (2 outpatient visits, 4 x 4 days resident in unit); Parts 2: up to 11 weeks (2 outpatient visits, 3 x 4 days resident in unit); Part 3: approximately 10 weeks (2 outpatient visits, 17 days resident in unit); Part 4: up to 11 weeks (2 outpatient visits and 4/10 days resident in unit).REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/0220
Date of REC Opinion
22 May 2014
REC opinion
Further Information Favourable Opinion