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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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

Key facts

Study ID

NCT00429728

Run by

GlaxoSmithKline

People needed

26

Starts

2006-11-01

Last updated by the study team

2009-05-18

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• GSK Investigational Site — Willingboro, New Jersey, United States

Full record on ClinicalTrials.gov

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