Absorption & elimination of radiolabelled GSK961081, version 1
Research type
Research Study
Full title
An open-label study in healthy male subjects, to determine the excretion balance and pharmacokinetics of [14C]-GSK961081, administered as a single intravenous microtracer (concomitant with an inhaled non-radiolabelled dose) and a single oral dose (15-009)
IRAS ID
187451
Contact name
Frans van den Berg
Contact email
Eudract number
2015-003442-98
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
GSK961081 (the study medicine) is an experimental new treatment for chronic obstructive pulmonary disease (COPD). People with COPD suffer from breathlessness, because the small tubes (bronchioles) that carry air in and out of the lungs have become scarred and narrowed, usually because of heavy smoking. The study medicine works by relaxing the airways, and making breathing easier.
The study medicine has already been tested in healthy people and patients. We’re doing this study, in healthy men, to find out the blood levels of the study medicine, and how the body gets rid of it. We’ll also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine, if participants consent to that research.
We will enrol 6 healthy men, aged 30–55 years. They will have 2 study sessions. In their first session, they’ll receive 1 dose of study medicine by slow injection into a vein and 1 dose by inhalation. In their second session, they’ll receive 1 dose of study medicine by mouth, as a liquid. We’ll ‘label’ the study medicine with a small amount of radioactivity, called carbon-14, so that we can detect traces of study medicine and its breakdown products in blood, urine, faeces and bile (a fluid produced by the liver to help digestion).
Participants will take up to 11 weeks to finish the study. They will make 1 outpatient visit and stay on the ward for at least 16 nights. Depending on the results of the study, they may stay on the ward for longer or make extra outpatient visits.
A pharmaceutical company GlaxoSmithKline is funding the study. The study will take place at 1 centre in London. We’ll recruit healthy participants by; advertising, word of mouth, volunteer databases and via our websites.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0665
Date of REC Opinion
5 Jan 2016
REC opinion
Further Information Favourable Opinion