A Study Of GW406381 In Volunteers With Moderate Hepatic Impairment - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00373243

Purpose

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
Hepatic Insufficiency	Drug: GW406381	Phase I

Drug Information available for: GW406381

U.S. FDA Resources

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

GW406381 pharmacokinetic parameters AUC and Cmax [ Time Frame: throughout the study ]

Secondary Outcome Measures:

GW406381 pharmacokinetic parameters Tmax, Total plasma clearance, and if data permits the t1/2 of GW406381 GW404347 pharmacokinetic parameters AUC and Cmax Ex vivo protein binding Clinical laboratory values, adverse events, vital signs and 12 lead ECG [ Time Frame: throughout the study ]

Enrollment:	24
Study Start Date:	October 2005

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373243

Locations

Hungary
GSK Investigational Site
Balantonfured, Hungary, 8230
GSK Investigational Site
Budapest, Hungary, 1062

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	CXA100754
Study First Received:	September 5, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00373243 History of Changes
Health Authority:	Hungary: National Institute of Pharmacy

Keywords provided by GlaxoSmithKline:

hepatic impairment pharmacokinetics

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Healthy
Hepatic Insufficiency

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases
Hepatic Insufficiency

ClinicalTrials.gov processed this record on May 06, 2009