A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
Phase 1
Completed
- Conditions
- Healthy Subjects
- Registration Number
- NCT00429728
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 clinical laboratory data day 1 through 24 hours post dose day 1 through 24 hours post dose adverse events day 1 through 72 hours post dose day 1 through 72 hours post dose
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which smoking affects GW876008 metabolism in healthy subjects?
How does the pharmacokinetics of GW876008 compare to other CYP1A2 substrates in smokers and non-smokers?
Are there specific biomarkers that correlate with GW876008 clearance rates in smokers versus non-smokers?
What adverse events are associated with GW876008 administration in healthy volunteer populations?
How does GlaxoSmithKline's GW876008 metabolism research inform drug development for CYP1A2-related compounds?
Trial Locations
- Locations (1)
GSK Investigational Site
🇺🇸Willingboro, New Jersey, United States
GSK Investigational Site🇺🇸Willingboro, New Jersey, United States