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

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00429728
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2007-01-30
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-15
• Last Update Posted: 2009-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
clinical laboratory data day 1 through 24 hours post dose	day 1 through 24 hours post dose
adverse events day 1 through 72 hours post dose	day 1 through 72 hours post dose

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Willingboro, New Jersey, United States