Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and UrgencyPhase 1NCT01286454
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
A Phase 1 study testing fesoterodine in people with Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency, run by Pfizer at 1 site in United States.
Trial summary
This Is A Study Of Bioavailability And Food Effect For Fesoterodine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
- What is being tested?
- fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 and/or female subjects between the ages of 18 and 55 years
Who cannot join
- Evidence or history of clinically significant disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Read the detailed description
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.
- Being tested
- fesoterodine
- Keywords
- BIOAVAILABILITY, FOOD EFFECT
- 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.
fesoterodineDrug
single dose of beads in capsule
fesoterodineDrug
single dose of beads in capsule
fesoterodineDrug
single dose of beads in capsule
fesoterodineDrug
single dose of beads in capsule
fesoterodineDrug
single dose of tablet
fesoterodineDrug
single dose of beads in capsule
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 4 mg fesoterodine IR beads in capsule under fasting condition Receives: Drug: fesoterodine |
| B | Experimental | 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition Receives: Drug: fesoterodine |
| C | Experimental | 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. Receives: Drug: fesoterodine |
| D | Experimental | 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. Receives: Drug: fesoterodine |
| E | Experimental | 4 mg fesoterodine ER tablets under fasting condition. Receives: Drug: fesoterodine |
| F | Experimental | 4 mg fesoterodine TBD % coated ER beads in capsule under fed condition. Receives: Drug: fesoterodine |
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 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Secondary outcomes (2)
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and UrgencyStudies 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
- 20 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
- NCT01286454
- Sponsor's protocol ID
- A0221068
- Status last verified
- Jan 2012
- First submitted
- 3 Dec 2010
- Last updated
- 26 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Dose, Randomized, Cross-Over Study To Estimate The Bioavailability And Food Effect Of 4 Mg Fesoterodine Extended Release Beads-In-Capsule Formulations Compared To Commercial Tablet Formulation In Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01286454
- Acronym / sponsor ID
- A0221068
- Keywords
- BIOAVAILABILITY, FOOD EFFECT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 9 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
Detailed description
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: fesoterodine4 mg fesoterodine IR beads in capsule under fasting condition |
| B | Experimental | Drug: fesoterodine4 mg fesoterodine 10% coated ER beads in capsule under fasting condition |
| C | Experimental | Drug: fesoterodine4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. |
| D | Experimental | Drug: fesoterodine4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. |
| E | Experimental | Drug: fesoterodine4 mg fesoterodine ER tablets under fasting condition. |
| F | Experimental | Drug: fesoterodine4 mg fesoterodine TBD % coated ER beads in capsule under fed condition. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and/or female subjects between the ages of 18 and 55 years
Key exclusion criteria (1 listed)
- Evidence or history of clinically significant 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 |
|---|---|---|
| fesoterodinesingle dose of beads in capsule | Drug | A |
| fesoterodinesingle dose of beads in capsule | Drug | B |
| fesoterodinesingle dose of beads in capsule | Drug | C |
| fesoterodinesingle dose of beads in capsule | Drug | D |
| fesoterodinesingle dose of tablet | Drug | E |
| fesoterodinesingle dose of beads in capsule | Drug | F |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT])
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose
AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Fesoterodine Metabolite (5-HMT)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) of 5-HMT.
Maximum Observed Plasma Concentration (Cmax) for Fesoterodine Metabolite (5-HMT)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
2 secondary outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Fesoterodine Metabolite (5-HMT)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Plasma Decay Half Life (t1/2) for Fesoterodine Metabolite (5-HMT)
Time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hrs post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 in people with Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency, run by Pfizer 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 1 inclusion and 1 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 26 Jan 2012. 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?
Yes. Results are posted in the registry (first posted 9 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 - ∞)] for Fesoterodine Metabolite (5-hydroxymethyltolterodine [5-HMT]) (time frame: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36 and 48 hours (hrs) post dose). The study lists 3 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 26 Jan 2012.