GSK2793660 - first doses in humans; version 1
Research type
Research Study
Full title
A randomised, double-blind (sponsor unblind), placebo-controlled, two part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single or repeat doses of GSK2793660, in healthy subjects (13-007)
IRAS ID
142997
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2013-001828-19
ISRCTN Number
xx
Clinicaltrials.gov Identifier
xx
Research summary
The study medicine is an experimental treatment for a type of lung disease, called non-cystic fibrosis bronchiectasis (non-CF BE). People with non-CF BE have airways that are scarred, enlarged, inflamed and make too much mucus. Patients have breathlessness and frequent lung infections. We hope the study medicine will reduce lung inflammation and mucus in patients with non-CF BE.
In this 2-part study (Parts A and B), we aim to assess side effects, blood levels, and effects of the study medicine. We’ll also test whether food affects blood levels.
48 healthy men and women (unable to have a baby), aged 18–55 years, will take part in the whole study.
In Part A, we’ll give 18 participants, up to 4 single doses of study medicine by mouth. It’s never been given to humans before, so we’ll start with a low dose, and increase the dose as the study progresses. Participants will take up to 15 weeks to finish the study. They’ll make 5 outpatient visits, and stay on the ward for up to 16 nights in total (up to 4 stays of 4 nights each).
In Part B, we’ll give up to 30 participants, 14 daily doses of the study medicine. We’ll decide the doses in Part B after we’ve reviewed the results of Part A. Participants will take up to 9 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for up to 18 nights in a row.
A pharmaceutical company (GlaxoSmithKline Research & Development Limited) is funding the study.
The study will take place at 1 centre in London. We’ll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1690
Date of REC Opinion
29 Nov 2013
REC opinion
Favourable Opinion