A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

• Status: Completed
• Trial end date: 2006-09-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

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