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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-01

Study Completion Date

2006-10-12

Brief Summary

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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.

Detailed Description

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Conditions

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Vomiting

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy subjects receiving GW679769

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

Group Type EXPERIMENTAL

GW679769

Intervention Type DRUG

GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning

Subjects with hepatic impairment receiving GW679769

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

Group Type EXPERIMENTAL

GW679769

Intervention Type DRUG

GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning

Interventions

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GW679769

GW679769 will be available in dose strength of 50 mg tablets. Subjects will receive two tablets of 50 mg orally once daily in the morning

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Gainesville, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

Countries

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United States

Study Documents

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