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

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.

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: GW876008

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline
• Investigators: Study Director: GSK Clinical Trials, MBChB, MFPM, GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2006

Study Registration Dates

• First Submitted: January 30, 2007
• First Submitted That Met QC Criteria: January 31, 2007
• First Posted (Estimate): February 1, 2007

Study Record Updates

• Last Update Posted (Estimate): May 18, 2009
• Last Update Submitted That Met QC Criteria: May 15, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: non-smokers; tolerability,; Pharmacokinetics,; healthy,; subjects,; smokers,
• Other Study ID Numbers: CRH103004