HealthyPhase 1NCT02160158
Study to Estimate the Relative Bioavailability Compared to Commercial Extended-release Tablet Formulation and the Effects of Food Or Sprinkling on Applesauce for Fesoterodine Sustained-release Beads-in-capsule Formulations in Healthy Adult Volunteers
A Phase 1 study testing Fesoterodine ER (fasted), Fesoterodine SR3 (fasted) and Fesoterodine SR3 (fed) in people with Healthy, run by Pfizer at 1 site in Belgium.
Trial summary
The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Fesoterodine ER (fasted), Fesoterodine SR3 (fasted) and Fesoterodine SR3 (fed)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2014to Dec 2014
- 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 and/or female subjects between the ages of 18 and 55 years; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Who cannot join
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
- Evidence or history of clinically significant urologic disease [urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-dose, Randomized, Crossover Study To Estimate The Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers
The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).
- Conditions
- Healthy
- Being tested
- Fesoterodine ER (fasted), Fesoterodine SR3 (fasted), Fesoterodine SR3 (fed), Fesoterodine ER (fed), Fesoterodine SR3 (sprinkle)
- Keywords
- Fesoterodine, SR3, SR4, bioavailability, pharmacokinetics, sprinkle, applesauce
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fesoterodine ER (fasted)Drug
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR3 (fasted)Drug
Fesoterodine SR3 4 mg (single dose)
Fesoterodine SR3 (fed)Drug
Fesoterodine SR3 4 mg (single dose) with high-fat meal
Fesoterodine ER (fed)Drug
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR3 (sprinkle)Drug
Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
Fesoterodine ER (fasted)Drug
Commercial Fesoterodine ER 4 mg (single dose)
Fesoterodine SR4 (fasted)Drug
Fesoterodine SR4 4 mg (single dose)
Fesoterodine SR4 (fed)Drug
Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
Fesoterodine ER (fed)Drug
Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
Fesoterodine SR4 (sprinkle)Drug
Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: Fesoterodine ER (fasted); Drug: Fesoterodine SR3 (fasted); Drug: Fesoterodine SR3 (fed); Drug: Fesoterodine ER (fed); Drug: Fesoterodine SR3 (sprinkle) |
| Cohort 2 | Experimental | Not described Receives: Drug: Fesoterodine ER (fasted); Drug: Fesoterodine SR4 (fasted); Drug: Fesoterodine SR4 (fed); Drug: Fesoterodine ER (fed); Drug: Fesoterodine SR4 (sprinkle) |
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 - 8)]
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: 48 hours
Maximum Observed Plasma Concentration (Cmax)
Measured: 48 hours
Secondary outcomes (3)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)
Measured: 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 48 hours
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 (estimated)
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
- NCT02160158
- Sponsor's protocol ID
- A0221099
- Other IDs
- 2014-001248-39, 2014
- Status last verified
- Jan 2015
- First submitted
- 6 Jun 2014
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. 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 Relative Bioavailability Compared To Commercial Extended-release Tablet Formulation And The Effects Of Food Or Sprinkling On Applesauce For Fesoterodine Sustained-release Beads-in-capsule Formulations In Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT02160158
- Acronym / sponsor ID
- A0221099
- Conditions
- Healthy
- Keywords
- Fesoterodine, SR3, SR4, bioavailability, pharmacokinetics, sprinkle, applesauce
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jun 2014 (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.
The purpose of this study is to evaluate the relative bioavailability of 2 new bead-in-capsule formulations compared to the commercial extended-release formulation (both fed and fasted) and to assess the effect of sprinkling the capsule contents on applesauce on the pharmacokinetics of 5 hydroxymethyl tolterodine (5-HMT).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Fesoterodine ER (fasted), Drug: Fesoterodine SR3 (fasted), Drug: Fesoterodine SR3 (fed), Drug: Fesoterodine ER (fed), Drug: Fesoterodine SR3 (sprinkle) |
| Cohort 2 | Experimental | Drug: Fesoterodine ER (fasted), Drug: Fesoterodine SR4 (fasted), Drug: Fesoterodine SR4 (fed), Drug: Fesoterodine ER (fed), Drug: Fesoterodine SR4 (sprinkle) |
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; Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Key exclusion criteria (3 listed)
- Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication
- History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon
- Evidence or history of clinically significant urologic disease [urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollacisuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections); Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes/day
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 ER (fasted)Commercial Fesoterodine ER 4 mg (single dose) | Drug | Cohort 1 |
| Fesoterodine SR3 (fasted)Fesoterodine SR3 4 mg (single dose) | Drug | Cohort 1 |
| Fesoterodine SR3 (fed)Fesoterodine SR3 4 mg (single dose) with high-fat meal | Drug | Cohort 1 |
| Fesoterodine ER (fed)Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal | Drug | Cohort 1 |
| Fesoterodine SR3 (sprinkle)Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce | Drug | Cohort 1 |
| Fesoterodine ER (fasted)Commercial Fesoterodine ER 4 mg (single dose) | Drug | Cohort 2 |
| Fesoterodine SR4 (fasted)Fesoterodine SR4 4 mg (single dose) | Drug | Cohort 2 |
| Fesoterodine SR4 (fed)Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal | Drug | Cohort 2 |
| Fesoterodine ER (fed)Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal | Drug | Cohort 2 |
| Fesoterodine SR4 (sprinkle)Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce | Drug | Cohort 2 |
Primary outcome
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Time frame: 48 hours
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
Time frame: 48 hours
3 secondary outcomes
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
Time frame: 48 hours
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 48 hours
Plasma Decay Half-Life (t1/2)
Time frame: 48 hours
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 15 Jan 2015.
- 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 ER (fasted), Fesoterodine SR3 (fasted) and Fesoterodine SR3 (fed) in people with Healthy, run by Pfizer at 1 site in Belgium.
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 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 15 Jan 2015. 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 Belgium. 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 - 8)] (time frame: 48 hours). 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 15 Jan 2015.