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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

NCT01577680 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2017-07-25

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Inhaled GSK573719/vilanterol

All subjects will receive a single dose of GSK573719/VI (125mcg/25mcg) in Treatment Period 1

DRUG

Inhaled GSK573719

All subjects will receive GSK573719 (125mcg) once daily for seven days in Treatment Period 2

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-03-05
Primary Completion
2012-06-29
Completion
2012-06-29

Countries

  • Hungary
  • Slovakia

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01577680 on ClinicalTrials.gov