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

• Status: Completed
• Trial end date: 2006-10-12
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Casopitant

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