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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Vomiting

Treatments: Drug: GW679769

Study type: Interventional

Funder types: Industry

Identifiers

NCT00359177

NKT102785

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Healthy subjects receiving GW679769

Experimental group

Description:

Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days.

Treatment:

Drug: GW679769

Subjects with hepatic impairment receiving GW679769

Experimental group

Description:

Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days.

Treatment:

Drug: GW679769