Last updated: 11/04/2018 06:03:44
A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
GSK study ID
CRH103004
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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.
Trial description: This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
Primary purpose:
Diagnostic
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
Timeframe: on Day 1 at pre-dose and over 72 hours post-dose.
Secondary outcomes:
12-lead ECG on day 1, 24 hours post dose, & follow up
Timeframe: on day 1, 24 hours post dose, & follow up
vital signs at screening & day 1 through 72 hours post dose
Timeframe: at screening & day 1 through 72 hours post dose
adverse events day 1 through 72 hours post dose
Timeframe: day 1 through 72 hours post dose
clinical laboratory data day 1 through 24 hours post dose
Timeframe: day 1 through 24 hours post dose
Interventions:
Enrollment:
26
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy Subjects
Product
emicerfont
Collaborators
Not applicable
Study date(s)
November 2006 to February 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 45 Years
Accepts healthy volunteers
Yes
- Healthy males or females.
- Normal ECG.
- Any serious medical disorder or condition.
- Any clinically significant laboratory abnormality.
Inclusion and exclusion 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).
Trial location(s)
Location
GSK Investigational Site
Willingboro, New Jersey, United States, 08046
Status
Study Complete
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-06-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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