Safety and blood levels of GSK573719; version 1
Research type
Research Study
Full title
A single-centre, open-label, sequential, cross-over study to examine the safety, tolerability and pharmacokinetics of 3 ascending single intravenous doses, a single 1000 µg oral dose and a single 1000 µg inhaled dose of GSK573719 in healthy male volunteers (HMR code 09-017).
IRAS ID
49540
Contact name
Steve Warrington
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2010-018429-20
ISRCTN Number
N/A
Research summary
The study medicine (GSK573719) is an experimental medicine for treating chronic obstructive pulmonary disease (COPD, also known as chronic bronchitis or emphysema). People with COPD suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. We hope that the study medicine will work for longer and have fewer side effects than existing treatments for COPD. We'll give 10 healthy men, aged 18??65 years, 5 single doses of study medicine. They??ll swallow 1 dose, breathe in 1 dose, and have 3 doses by slow injection into a vein. No one will take dummy medicine. The study medicine has never before been given to humans by injection into a vein, so We'll start with a small dose and increase the dose as the study progresses. We aim to find out its side effects and blood levels. We'll compare blood levels of the study medicine after an injection with those after a dose taken by mouth or inhalation. Participants will take about 10 weeks to finish the study. They??ll make up to 3 outpatient visits, and stay on the ward for 15 nights. 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 (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.
REC name
London - Brent Research Ethics Committee
REC reference
10/H0717/18
Date of REC Opinion
6 Apr 2010
REC opinion
Favourable Opinion