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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014