A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

An Open-label, Non-randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment

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.

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