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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00429728
First Posted: February 1, 2007
Last Update Posted: May 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00429728     History of Changes
Other Study ID Numbers: CRH103004
First Submitted: January 30, 2007
First Posted: February 1, 2007
Last Update Posted: May 18, 2009
Last Verified: May 2009

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