PharmacokineticsPhase 1NCT00731562
An Investigation Of The Effects Of Food On The Absorption Of A Varenicline Controlled Release Formulation
A Phase 1 study of Pharmacokinetics and Bioavailability, run by Pfizer at 2 sites in United States.
Trial summary
1. To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions. 2. To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Bioavailability, Smoking Cessation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Sep 2008
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adult smokers
- 18 to 55 years of age
Who cannot join
- Sensitivity to varenicline
- Illegal drug use
- Pregnant or nursing females
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pfizer Investigational Site
East Grand Forks, Minnesota, 56721
Pfizer Investigational Site
Fargo, North Dakota, 58104
About this study
Official title: Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers
- To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
- To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.
- Conditions
- Pharmacokinetics, Bioavailability, Smoking Cessation
- Being tested
- Varenicline Tartrate Controlled Release
- Keywords
- food, varenicline, pharmacokinetics, bioavailability
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varenicline Tartrate Controlled ReleaseDrug
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions
Varenicline Tartrate Controlled ReleaseDrug
A single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions
| Study group | Role | What they receive |
|---|---|---|
| Varenicline Controlled Release, Fasted | Experimental | Not described Receives: Drug: Varenicline Tartrate Controlled Release |
| Varenicline Controlled Release, Fed | Experimental | Not described Receives: Drug: Varenicline Tartrate Controlled Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
Measured: 5 days
Maximum plasma concentration of varenicline
Measured: 1 day
Secondary outcomes (1)
Safety measures including adverse events
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731562
- Sponsor's protocol ID
- A3051088
- Status last verified
- Jan 2010
- First submitted
- 7 Aug 2008
- Last updated
- 11 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, Open-Label, Randomized, Single-Dose, Two-Way Crossover Study To Evaluate The Effect Of Food On The Oral Bioavailability Of A Varenicline Controlled Release Formulation In Healthy Adult Smokers
- ClinicalTrials.gov ID
- NCT00731562
- Acronym / sponsor ID
- A3051088
- Conditions
- Pharmacokinetics, Bioavailability, Smoking Cessation
- Keywords
- food, varenicline, pharmacokinetics, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 11 Aug 2008 (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.
- To estimate the absorption of a single oral dose of a controlled release varenicline tablet under fed and fasted conditions.
- To evaluate the pharmacokinetics, safety, and tolerability of a single dose of a varenicline controlled release tablet under fed and fasted conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varenicline Controlled Release, Fasted | Experimental | Drug: Varenicline Tartrate Controlled Release |
| Varenicline Controlled Release, Fed | Experimental | Drug: Varenicline Tartrate Controlled Release |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male or female adult smokers
- 18 to 55 years of age
Key exclusion criteria (3 listed)
- Sensitivity to varenicline
- Illegal drug use
- Pregnant or nursing females
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 |
|---|---|---|
| Varenicline Tartrate Controlled ReleaseA single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fasted conditions | Drug | Varenicline Controlled Release, Fasted |
| Varenicline Tartrate Controlled ReleaseA single, 2.4 mg dose of a varenicline controlled release tablet administered orally under fed conditions | Drug | Varenicline Controlled Release, Fed |
Primary outcome
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf).
Time frame: 5 days
Maximum plasma concentration of varenicline
Time frame: 1 day
1 secondary outcome
Safety measures including adverse events
Time frame: 5 days
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 11 Jan 2010.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Pharmacokinetics and Bioavailability, run by Pfizer at 2 sites 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 2 inclusion and 3 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 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Varenicline area under the curve (AUC) from time of study medication administration to last quantifiable plasma concentration (AUClast) and AUC from time of study medication administration to infinity (AUCinf). (time frame: 5 days). The study lists 2 primary outcomes in all. 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 11 Jan 2010.