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

Completed · Phase 1

Conditions studied: Vomiting

In brief

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.

Key facts

Study ID

NCT00359177

Run by

GlaxoSmithKline

People needed

24

Starts

2005-12-01

Expected to finish

2006-10-12

Last updated by the study team

2017-09-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• GSK Investigational Site — Gainesville, Florida, United States
• GSK Investigational Site — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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