Observational Study Evaluating The Processing Or Breakdown Of GW679769 In Subjects With Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 9/27/2017 |
| Start Date: | December 1, 2005 |
| End Date: | October 12, 2006 |
An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Hepatic Impairment
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.
process or breakdown the study drug GW679769 in their bodies as compared to healthy subjects.
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
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