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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429728

Enrollment

Registered

2007-02-01

Start date

2006-11-30

Completion date

Unknown

Last updated

2009-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

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

Brief summary

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

Interventions

DRUGGW876008

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026