Healthy SubjectsPhase 1NCT00429728
A Study To Investigate The Metabolism Of GW876008 In Smokers Compared To Non-Smokers.
A Phase 1 study testing GW876008 in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
Trial summary
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- GW876008
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
GSK Investigational Site
Willingboro, New Jersey, 08046
About this study
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.
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
- Conditions
- Healthy Subjects
- Being tested
- GW876008
- Keywords
- Pharmacokinetics,, tolerability,, healthy,, subjects,, smokers,, non-smokers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW876008Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood levels of GW876008 collected on Day 1 at pre-dose and over 72 hours post-dose.
Measured: 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
Measured: on day 1, 24 hours post dose, & follow up
vital signs at screening & day 1 through 72 hours post dose
Measured: at screening & day 1 through 72 hours post dose
adverse events day 1 through 72 hours post dose
Measured: day 1 through 72 hours post dose
clinical laboratory data day 1 through 24 hours post dose
Measured: day 1 through 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MBChB, MFPM, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429728
- Sponsor's protocol ID
- CRH103004
- Status last verified
- May 2009
- First submitted
- 30 Jan 2007
- Last updated
- 18 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00429728
- Acronym / sponsor ID
- CRH103004
- Conditions
- Healthy Subjects
- Keywords
- Pharmacokinetics,, tolerability,, healthy,, subjects,, smokers,, non-smokers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- First posted
- 1 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the effect of smoking on the metabolism of a single oral dose of GW876008.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GW876008 | Drug | – |
Primary outcome
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.
4 secondary outcomes
12-lead ECG on day 1, 24 hours post dose, & follow up
Time frame: on day 1, 24 hours post dose, & follow up
vital signs at screening & day 1 through 72 hours post dose
Time frame: at screening & day 1 through 72 hours post dose
adverse events day 1 through 72 hours post dose
Time frame: day 1 through 72 hours post dose
clinical laboratory data day 1 through 24 hours post dose
Time frame: day 1 through 24 hours post dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MBChB, MFPM study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GW876008 in people with Healthy Subjects, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2009.