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A Study to Assess the Effects of GSK573719/VI Combination and GSK573719 Monotherapy in Subjects With Moderate Hepatic Impairment and Matched Healthy Volunteers

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
An Open-label, Non-randomized, Pharmacokinetic and Safety Study of Single Dose GSK573719 + GW643444 (VI) Combination and Repeat Doses of GSK573719 in Healthy Subjects and in Subjects With Moderate Hepatic Impairment

Clinical Trial Summary

This study will assess the safety and pharmacokinetics of GSK573719 and GSK573719/vilanterol combination in healthy subjects and subjects with moderate hepatic impairment. The results of this study will provide guidance on the use of the product in patients with hepatic impairment.

Clinical Trial Description

GSK573719 is being developed as a monotherapy and in combination with vilanterol for the treatment of Chronic Obstructive Pulmonary Disease (COPD). This study will assess the pharmacokinetics and safety of inhaled GSK573719/ vilanterol (VI) and GSK573719 in healthy subjects and in subjects with moderate hepatic impairment. Nine subjects with moderate hepatic impairment will be recruited, together with nine matched healthy volunteers.

There is a possibility that when used by patients with impaired hepatic function the pharmacokinetics of inhaled GSK573719 or GSK572719/VI may be altered. The results of this study will therefore provide guidance on the use of GSK573719 and GSK573719/VI in moderate hepatically impaired patients. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01577680
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date March 5, 2012
Completion date June 29, 2012
View Details
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