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

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00429728
• Other study ID #: CRH103004
• Status: Completed
• Phase: Phase 1
• First received: January 30, 2007
• Last updated: May 15, 2009
• Start date: November 2006

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• GW876008

Locations

Country	Name	City	State
United States	GSK Investigational Site	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12-lead ECG on day 1, 24 hours post dose, & follow up		on day 1, 24 hours post dose, & follow up
Secondary	vital signs at screening & day 1 through 72 hours post dose		at screening & day 1 through 72 hours post dose
Secondary	adverse events day 1 through 72 hours post dose		day 1 through 72 hours post dose
Secondary	clinical laboratory data day 1 through 24 hours post dose		day 1 through 24 hours post dose