GSK3036656 – first doses in humans; v1
Research type
Research Study
Full title
A double blind, placebo-controlled first time in human study to evaluate the safety, tolerability and pharmacokinetics of single and repeat doses of GSK3036656 in healthy adult volunteers (15-007).
IRAS ID
221307
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Ltd
Eudract number
2015-003654-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine, GSK3036656, is an experimental treatment for tuberculosis (TB), a disease caused by the bacterium, Mycobacterium tuberculosis. TB is difficult to treat and people have to take a cocktail of drugs for several months. Some strains of TB are now resistant to all currently available drugs. We hope that GSK3036656 will become part of a new combination treatment for TB and that it will treat TB strains currently resistant to other drugs.
We’ll test single and repeated doses of GSK3036656 in up to 58 healthy volunteers, aged 18–55 years, to find out its side effects and blood levels. GSK3036656 has never been given to humans before, so, in each part, we’ll start with a small dose, and increase the dose as the study progresses. We’ll also test whether food affects blood levels of GSK3036656.
The study will be done in 2 parts:
In Part A, we’ll give 18 participants single oral doses of GSK3036656 or placebo. Each participant will have up to 4 study sessions, in which they’ll take a single dose of GSK3036656 or placebo. Participants will take about 12 weeks to finish the study. They’ll stay on the ward for 4 nights in each session and make 4 outpatient visits.
In Part B, we’ll give up to 40 participants daily doses of GSK3036656 or placebo for 14 days. Participants will take about 8 weeks to finish the study. They’ll stay on the ward for 17 nights and make 4 outpatient visits. For some groups, we might discharge participants from the ward earlier and ask them to return for daily outpatient visits, depending on the results from previous groups.
A pharmaceutical company (GlaxoSmithKline) is funding the study.The study will take place at 1 centre in London.
REC name
HSC REC B
REC reference
17/NI/0016
Date of REC Opinion
2 Mar 2017
REC opinion
Further Information Favourable Opinion