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

Study Overview
=================
Brief 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.

Official Title
-----------------
An Open-Label, Non-Randomized, Pharmacokinetic and Safety Study of Multiple Oral Doses of GW679769 in Subjects With Hepatic Impairment

Conditions
-----------------
Vomiting

Intervention / Treatment
-----------------
* Drug: GW679769


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subjects receiving GW679769<br>Healthy Subjects will receive single 100 milligram (mg) oral doses of GW679769 for five consecutive days. | Drug: GW679769<br>* 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<br>|
| Experimental: Subjects with hepatic impairment receiving GW679769<br>Subjects with hepatic impairment will receive single 100 mg oral doses of GW679769 for five consecutive days. | Drug: GW679769<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve (AUC) of single oral dose of GW679769 in healthy subjects | Blood samples for pharmacokinetics (PK) analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| AUC of multiple oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| AUC of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| AUC of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| Maximum observed concentration (Cmax) of single oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| Cmax of multiple oral dose of GW679769 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of single oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| Cmax of multiple oral dose of GW679769 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GW679769 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| AUC of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| AUC of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| AUC of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| AUC of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. AUC will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of single oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| Cmax of multiple oral dose of GSK525060 in healthy subjects | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 
| Cmax of single oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours | 
| Cmax of multiple oral dose of GSK525060 in subjects with mild and moderate hepatic impairment | Blood samples for PK analysis will be collected at the indicated time points. Cmax will be calculated from plasma GSK525060 concentration. | Day 1 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, and 24 hours, Pre-dose (Day 3 and 4), Day 5 Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, and 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emesis liver problems hepatic impairment GW679769