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A Study to Assess the Effects of Repeat Doses of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Severe Impairment.

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
An Open-label, Non-randomized Pharmacokinetic and Safety Study of Repeat Doses of Fluticasone Furoate and GW642444M Combination in Healthy Subjects and in Subjects With Severe Renal Impairment.

Clinical Trial Summary

This study will assess the saftey of giving fluticasone furoate 200mcg/GW642444M 25mcg once daily for 7 days to patients with severe renal imparement. The results of this study will aid in deciding whether a FF/GW642444M doseadjustment is justified in subjects with severe renal impairment and in estimating any such adjustments.

Clinical Trial Description

This is an open-label, non-randomized study which will assess the pharmacokinetics and safety following 7 days once daily dose of inhaled FF/ GW642444M (200/25mcg) in subjects with renal impairment. Nine subjects with severe renal impairment (as defined by a Clcr<30mL/min) will be recruited along with healthy control subjects (as defined by a Clcr>80mL/min matched to the severe subjects based on gender, ethnicity, body mass index (±15%) and age (±5 years)). All subjects will receive fluticasone furoate 200mcg/GW642444M 25mcg once daily for 7 days. The results of this study will aid in deciding whether a FF/GW642444M dose adjustment is justified in subjects with severe renal impairment and in estimating any such adjustments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01266980
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 1
Start date November 18, 2010
Completion date March 22, 2011
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