Absorption & elimination of radiolabelled GSK2269557; 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]-GSK2269557, administered as a single intravenous microtracer (concomitant with an inhaled non-radiolabelled dose) and a single oral dose (17-003).
IRAS ID
233426
Contact name
Denisa Wilkes
Contact email
Sponsor organisation
Glaxo Smith Kline (GSK)
Eudract number
2017-002347-16
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
People with lung diseases, such as asthma and chronic obstructive pulmonary disease (COPD), have swelling and inflammation (redness and irritation) of the small tubes (airways) that carry air in and out of the lung. Over time, this can cause narrowing of the airways, which makes breathing difficult. GSK2269557 (the study medicine) is an experimental new medicine for reducing inflammation of the small tubes in the lungs. We hope that the study medicine will work by reducing the narrowing of the airways caused by allergens and irritants, like smoke, making breathing easier for people with lung diseases.
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, how the body gets rid of it, and how long that takes. We'll also determine if it has any important side effects.
We’ll enrol 6 healthy men, aged 30–55 years. They’ll have 2 study sessions. In session 1, they’ll receive 1 dose of study medicine by slow injection into a vein, and 1 dose by inhalation. In session 2, 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 it, and its breakdown products, in blood, urine, faeces (‘poo’) and bile (a fluid produced by the liver to help digestion).
Participants will take up to 9 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 16 nights (8 nights in each session). They might stay on the ward for longer during session 2, depending on the results.
A pharmaceutical company (GlaxoSmithKline) is funding the study.The study will take place at 1 centre in London.
REC name
London - Harrow Research Ethics Committee
REC reference
17/LO/1459
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion