Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00359177

Purpose

The purpose of the study is to evaluate how subjects with mild or moderate liver problems process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.

Condition	Intervention
Renal Impairment	Drug: GW679769

Drug Information available for: GW679769

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Hepatic Impairment

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	24
Study Start Date:	December 2005

Eligibility

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

Criteria

Inclusion criteria:

Healthy or have mild or moderate hepatic impairment
Females: Non-childbearing (hysterectomy, bilateral oophorectomy, post-menopausal), childbearing (negative pregnancy test, abstinence, double-barrier contraception, vasectomized partner)
Negative for Hepatitis B and C(healthy subjects)
Negative drug, alcohol and HIV tests

Exclusion criteria:

Fluctuating or rapidly deteriorating hepatic function or abnormal kidney function
Encephalopathy
Active peptic ulcer disease
Drug or alcohol abuse
Pregnant or lactating
Esophageal bleeding
Heart failure
Infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359177

Locations

United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32809
GSK Investigational Site
Gainesville, Florida, United States, 32608

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKT102785
Study First Received:	July 28, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00359177
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

emesis liver problems hepatic impairment GW679769

Study placed in the following topic categories:

Liver Diseases
Digestive System Diseases
Vomiting

ClinicalTrials.gov processed this record on January 16, 2009