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Completed

NCT Number: NCT00429728

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

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Willingboro, New Jersey, 08046, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

GW876008

Drug

Primary outcomes

  1. 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 outcomes

  1. 12-lead ECG on day 1, 24 hours post dose, & follow up

    Time frame: on day 1, 24 hours post dose, & follow up

  2. vital signs at screening & day 1 through 72 hours post dose

    Time frame: at screening & day 1 through 72 hours post dose

  3. adverse events day 1 through 72 hours post dose

    Time frame: day 1 through 72 hours post dose

  4. clinical laboratory data day 1 through 24 hours post dose

    Time frame: day 1 through 24 hours post dose

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2006
First posted
Feb 1, 2007
Registry last updated
May 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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