Observational Pharmacokinetic Study Of GW679769 In Subjects With Renal Impairment

Completed · Phase 1

Conditions studied: Vomiting

In brief

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.

Key facts

Study ID

NCT00358813

Run by

GlaxoSmithKline

People needed

18

Starts

2006-09-08

Expected to finish

2008-08-22

Last updated by the study team

2017-08-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Miramar, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States
• GSK Investigational Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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