Urinary Bladder, OveractivePhase 1NCT01566760
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
A Phase 1 study testing fesoterodine fumarate in people with Urinary Bladder, Overactive, run by Pfizer at 1 site in Singapore.
Trial summary
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- fesoterodine fumarate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- May 2012to Jul 2012
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and/or female subjects between 21 and 55 years of age(inclusive).
Who cannot join
- Evidence or history of clinically significant disease.
- Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- fesoterodine fumarate
- Keywords
- food effect, bioavailability, pharmacokinetics, fesoterodine, 5-hydroxymethyl tolterodine, treatment of overactive bladder
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fesoterodine fumarateDrug
One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
fesoterodine fumarateDrug
One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
fesoterodine fumarateDrug
One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
fesoterodine fumarateDrug
One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
fesoterodine fumarateDrug
one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
| Study group | Role | What they receive |
|---|---|---|
| Treatment A, Cohort 1 | Experimental | Not described Receives: Drug: fesoterodine fumarate |
| Treatment B, Cohort 2 | Experimental | Not described Receives: Drug: fesoterodine fumarate |
| Treatment C, Cohort 1 | Experimental | Not described Receives: Drug: fesoterodine fumarate |
| Treatment D, Cohort 2 | Experimental | Not described Receives: Drug: fesoterodine fumarate |
| Treatment E, Cohort 1 and/or Cohort 2 | Active comparator | Not described Receives: Drug: fesoterodine fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Maximum Observed Plasma Concentration (Cmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Secondary outcomes (3)
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Plasma Decay Half-Life (t1/2)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 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 posted29 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies 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
- Primary purpose
- Basic science
- 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)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566760
- Sponsor's protocol ID
- A0221069
- Status last verified
- Jul 2012
- First submitted
- 27 Mar 2012
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01566760
- Acronym / sponsor ID
- A0221069
- Conditions
- Urinary Bladder, Overactive
- Keywords
- food effect, bioavailability, pharmacokinetics, fesoterodine, 5-hydroxymethyl tolterodine, treatment of overactive bladder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 29 Mar 2012 (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 (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A, Cohort 1 | Experimental | Drug: fesoterodine fumarate |
| Treatment B, Cohort 2 | Experimental | Drug: fesoterodine fumarate |
| Treatment C, Cohort 1 | Experimental | Drug: fesoterodine fumarate |
| Treatment D, Cohort 2 | Experimental | Drug: fesoterodine fumarate |
| Treatment E, Cohort 1 and/or Cohort 2 | Active comparator | Drug: fesoterodine fumarate |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects between 21 and 55 years of age(inclusive).
Key exclusion criteria (2 listed)
- Evidence or history of clinically significant disease.
- Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).
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 |
|---|---|---|
| fesoterodine fumarateOne capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose | Drug | Treatment A, Cohort 1 |
| fesoterodine fumarateOne capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose | Drug | Treatment B, Cohort 2 |
| fesoterodine fumarateOne capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose | Drug | Treatment C, Cohort 1 |
| fesoterodine fumarateOne capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose | Drug | Treatment D, Cohort 2 |
| fesoterodine fumarateone extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose | Drug | Treatment E, Cohort 1 and/or Cohort 2 |
Primary outcome
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
3 secondary outcomes
Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.
Plasma Decay Half-Life (t1/2)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 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 19 Aug 2016.
- 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
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 fesoterodine fumarate in people with Urinary Bladder, Overactive, run by Pfizer at 1 site in Singapore.
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 1 inclusion and 2 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 19 Aug 2016. 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 Singapore. 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?
Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.). 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 19 Aug 2016.