Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

This study has been completed.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00358813

Purpose

The purpose of the study is to evaluate how subjects with mild or moderate kidney 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 Renal Impairment

Further study details as provided by GlaxoSmithKline:

Estimated Enrollment:	18
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion criteria:

Healthy or have mild or moderate renal impairment.
Females must be of non-childbearing potential(hysterectomy, bilateral oophorectomy, post-menopausal) OR childbearing and must have a negative pregnancy test and meet/comply with one of the following: abstinence, double-barrier contraception, vasectomized partner).
Be negative for Hepatitis B and C.
Have negative results on drug, alcohol and HIV tests.
Have stable renal function.

Exclusion criteria:

Have a peptic ulcer.
Abuse drugs or alcohol.
Are pregnant or lactating.
Have heart failure.
Have uncontrolled emesis.
Have an infection.
Have taken or received inducers or inhibitors of CYP3A4 or CYP3A5 within 14 days of study start.
Active peptic ulcer disease.
Digoxin use.
Laboratory results that show low iron or pepsinogen levels, AST and CK level >1,5 ULN, or that show stool is positive for occult blood.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358813

Locations

United States, Florida
GSK Investigational Site
Orlando, Florida, United States, 32809
GSK Investigational Site
Miramar, Florida, United States, 33025
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKT102783
Study First Received:	July 28, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00358813
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

emesis
kidney problems
renal impairment
GW679769

Study placed in the following topic categories:

Vomiting

ClinicalTrials.gov processed this record on January 16, 2009