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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00429728
First received: January 30, 2007
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Drug: GW876008
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose. [ Time Frame: on Day 1 at pre-dose and over 72 hours post-dose. ]

Secondary Outcome Measures:
  • 12-lead ECG on day 1, 24 hours post dose, & follow up [ Time Frame: on day 1, 24 hours post dose, & follow up ]
  • vital signs at screening & day 1 through 72 hours post dose [ Time Frame: at screening & day 1 through 72 hours post dose ]
  • adverse events day 1 through 72 hours post dose [ Time Frame: day 1 through 72 hours post dose ]
  • clinical laboratory data day 1 through 24 hours post dose [ Time Frame: day 1 through 24 hours post dose ]

Enrollment: 26
Study Start Date: November 2006
Intervention Details:
    Drug: GW876008
    Other Name: GW876008
  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429728

Locations
United States, New Jersey
GSK Investigational Site
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MBChB, MFPM GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00429728     History of Changes
Other Study ID Numbers: CRH103004
Study First Received: January 30, 2007
Last Updated: May 15, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Pharmacokinetics,
tolerability,
healthy,
subjects,
smokers,
non-smokers

ClinicalTrials.gov processed this record on April 17, 2014