GSK233705 and GW642444 Safety, Blood levels and Effects in Japanese
Research type
Research Study
Full title
A single centre, randomised, placebo-controlled, four-way cross over study to assess the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of GSK233705 and GW642444 as monotherapies and in combination in healthy Japanese subjects.
IRAS ID
7260
Contact name
Daryl Bendel
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2008-004267-19
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
We tested two experimental new medicines for treating chronic obstructive pulmonary disease (COPD). Both study medicines are of a type that are currently used to treat COPD. But this will be the first time that both study medicines will be given together to Japanese people. We hope that the study medicines will work together by relaxing the airways, and making it easier to breathe. The medicines work in slightly different ways, so we hope that when they-re given together, the airways will relax more than after either medicine alone. Thestudy medicines, both separately and together, have already been given to non-Japanese people. Because the study sponsor is planning to market this medicine in Japan, we need test them in healthy Japanese people. We're doing this study to find out whether there are any important side effects, how much of the study medicines get into the bloodstream and how long does the body take to get rid of them, when they're inhaled separately or together in Japanese people. This study consists of 4 periods of 2 nights and 3 days in the clinical unit. One of the global pharmaceutical companies is funding this research and CRO company called InCROM Europe will be recruiting the healthy Japanese volunteers.
REC name
London - Brent Research Ethics Committee
REC reference
08/H0717/62
Date of REC Opinion
7 Nov 2008
REC opinion
Further Information Favourable Opinion