A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-19

Study Completion Date

2006-09-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects receiving GW406381

Subjects will receive single oral dose of 20 milligram (mg) of GW406381.

Group Type EXPERIMENTAL

GW406381

Intervention Type DRUG

GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.

Interventions

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GW406381

GW406381 will be available as 10 mg hard gelatin capsules. Subjects will receive two capsules of 10 mg to make 20 mg dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects or subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9
* Body weight less = 100 kg
* Body mass index (BMI) within range of 19 - 32 32kg/m2

Exclusion Criteria

* Presence of any other significant disease
* Use of any medication within the 2 weeks prior to dosing, unless approved by both the investigator and GSK personnel

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes