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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: GW876008

Study type

Interventional

Funder types

Industry

Identifiers

CRH103004

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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).