A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Pain

Treatments: Drug: GW406381

Study type: Interventional

Funder types: Industry

Identifiers

NCT00373243

CXA100754

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Subjects receiving GW406381

Experimental group

Description:

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

Treatment:

Drug: GW406381