NCT00429728

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Last Updated

May 18, 2009

Status Verified

May 1, 2009

First QC Date

January 30, 2007

Last Update Submit

May 15, 2009

Conditions

Healthy Subjects

Keywords

Pharmacokinetics,tolerability,healthy,subjects,smokers,non-smokers

Outcome Measures

Primary Outcomes (1)

  • Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.

    on Day 1 at pre-dose and over 72 hours post-dose.

Secondary Outcomes (4)

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

    on day 1, 24 hours post dose, & follow up

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

    at screening & day 1 through 72 hours post dose

  • adverse events day 1 through 72 hours post dose

    day 1 through 72 hours post dose

  • clinical laboratory data day 1 through 24 hours post dose

    day 1 through 24 hours post dose

Interventions

GW876008DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Willingboro, New Jersey, 08046, United States

Location

MeSH Terms

Interventions

GW 876008

Study Officials

  • GSK Clinical Trials, MBChB, MFPM

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

November 1, 2006

Last Updated

May 18, 2009

Record last verified: 2009-05

Locations

US(1)