drugset / Trial / NCT00373243

A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment

NCT00373243 ↗

Phase 1 Completed 24 enrolled GlaxoSmithKline
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2005-10-19
Primary completion
2006-09-26
Completion
2006-09-26

Drugs

EvaluationDrugModalityDoseRoute
Subject GW406381 Small molecule 20 mg Oral

Indications

No indication recorded.