A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.

Study Overview
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Brief Summary
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This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.

Official Title
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An Open-Label, Parallel Group, Single Session Study Comparing the Pharmacokinetics of a Single Oral Dose of GW876008 Administered to Healthy Volunteer Smokers and Healthy Volunteer Non-Smokers.

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: GW876008


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy males or females. Normal ECG. Non-smokers (abstinence from smoking for at least 6 months before the start of the study) or smokers who smoke between 10 and 30 cigarettes, inclusive, per day, for at least 2 months prior to screening. Subjects must agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample. Exclusion Criteria: Any serious medical disorder or condition. Any clinically significant laboratory abnormality. History of psychiatric illness. Any history of suicidal attempts or behavior. Active peptic ulcer disease. Positive faecal occult blood. Current or recent (within one year) gastrointestinal disease; a history of malabsorption, oesophageal reflux, irritable bowel syndrome; frequent (more than once a week) occurrence of heartburn; or any surgical intervention (e.g., cholecystectomy) which would be expected to influence the absorption of drugs. Female subjects who are currently or who are planning to become pregnant or who are lactating (from screening through at least 8 weeks after receiving study drug).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW876008|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose. |  | on Day 1 at pre-dose and over 72 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-lead ECG on day 1, 24 hours post dose, & follow up |  | on day 1, 24 hours post dose, & follow up | 
| vital signs at screening & day 1 through 72 hours post dose |  | at screening & day 1 through 72 hours post dose | 
| adverse events day 1 through 72 hours post dose |  | day 1 through 72 hours post dose | 
| clinical laboratory data day 1 through 24 hours post dose |  | day 1 through 24 hours post dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics,, tolerability,, healthy,, subjects,, smokers,, non-smokers