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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
January 30, 2007
February 1, 2007
May 18, 2009
November 2006
Not Provided
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. ]
Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
Complete list of historical versions of study NCT00429728 on ClinicalTrials.gov Archive Site
  • 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 ]
12-lead ECG on day 1, 24 hours post dose, & follow up vital signs at screening & day 1 through 72 hours post dose adverse events day 1 through 72 hours post dose clinical laboratory data day 1 through 24 hours post dose
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Healthy Subjects
Drug: GW876008
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
Not Provided
Not Provided

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).
Sexes Eligible for Study: All
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00429728
CRH103004
Not Provided
Not Provided
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials, MBChB, MFPM GlaxoSmithKline
GlaxoSmithKline
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP