Healthy SubjectsPhase 1NCT00369304
Study Evaluating the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate
A Phase 1 study testing pharmacokinetic (how the body absorbs and eliminates) interaction in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- pharmacokinetic (how the body absorbs and eliminates) interaction
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2006to Aug 2006
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
- Men and women, aged 18 to 50 years. Women of non-childbearing potential may be included.
- Body mass index in the range of 18 to 30 kg/meter squared and body weight equal to or greater than 50 kg.
- Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12 lead electrocardiogram (graphic trace of the pattern of your heart beat).
- Non-smoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history. Must abstain from smoking during inpatient stay.
- Have a high probability for compliance with and completion of the study.
About this study
Official title: A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.
This is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.
- Conditions
- Healthy Subjects
- Being tested
- pharmacokinetic (how the body absorbs and eliminates) interaction
- Keywords
- Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmacokinetic (how the body absorbs and eliminates) interactionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2006
- Study completionAug 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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369304
- Sponsor's protocol ID
- 3189A1-103
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2006
- Last updated
- 7 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, 2-Period Crossover Study to Determine the Pharmacokinetics of the Potential Drug Interaction Between CYP2C9 Inhibitor and Substrate.
- ClinicalTrials.gov ID
- NCT00369304
- Acronym / sponsor ID
- 3189A1-103
- Conditions
- Healthy Subjects
- Keywords
- Health
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 29 Aug 2006 (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 is an open-label, randomized, 2-period crossover, inpatient study to be performed in healthy subjects. The study will consist of 2 treatment periods: There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design. Doses of test article will be administered after an overnight fast of at least 10 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| pharmacokinetic (how the body absorbs and eliminates) interaction | Drug | – |
Primary outcome
To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.
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 7 Aug 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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pharmacokinetic (how the body absorbs and eliminates) interaction in people with Healthy Subjects, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
To evaluate the effects of a single oral dose of AGG-523 on the pharmacokinetic profile of a single oral dose of tolbutamide in healthy subjects.. 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 7 Aug 2009.