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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00373243 |
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.
Condition | Intervention | Phase |
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Hepatic Insufficiency |
Drug: GW406381 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study |
Official Title: | An Open-Label, Non-Randomised Study of 20 mg GW406381 Single Dose Pharmacokinetics in Healthy Subjects and in Volunteers With Moderate Hepatic Impairment |
Enrollment: | 24 |
Study Start Date: | October 2005 |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
Exclusion criteria:
Hungary | |
GSK Investigational Site | |
Balantonfured, Hungary, 8230 | |
GSK Investigational Site | |
Budapest, Hungary, 1062 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | CXA100754 |
Study First Received: | September 5, 2006 |
Last Updated: | October 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00373243 |
Health Authority: | Hungary: National Institute of Pharmacy |
hepatic impairment
pharmacokinetics |
Liver Diseases Digestive System Diseases Healthy Hepatic Insufficiency |