A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: GW406381

• Registration Number: NCT00373243
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This study will assess the pharmacokinetics and tolerability of a single dose of GW406381 in subjects with moderate hepatic impairment in comparison to matched healthy volunteers. The hepatically impaired and healthy groups will be given a single 20 mg oral dose of GW406381. Blood samples for PK analysis will be collected pre-dose and over the 72 hours post dosing. Subjects will be housed from the evening before dosing until 24 hours after dosing. A follow-up visit will be conducted between 7 to 10 days from the last dose of study drug.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-10-19
• Study First Submitted: 2006-09-05
• Study First Submitted QC: 2006-09-05
• Study First Posted: 2006-09-07
• Primary Completion: 2006-09-26
• Study Completion: 2006-09-26
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subjects receiving GW406381	GW406381	Subjects will receive single oral dose of 20 milligram (mg) of GW406381.

Primary Outcome Measures

Name	Time	Method
GW406381 pharmacokinetic parameters AUC and Cmax	throughout the study

Secondary Outcome Measures

Name	Time	Method
GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG	throughout the study

Trial Locations

Locations (1)

GSK Investigational Site; 🇭🇺 Budapest, Hungary