Neurogenic Detrusor OveractivityPhase 1NCT04452838

Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer

A Phase 1 study testing Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B) and Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B) in people with Neurogenic Detrusor Overactivity, run by Pfizer at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administered Intact. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Neurogenic Detrusor Overactivity
What is being tested?: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B) and Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteBelgium
Study dates: 26 Jun 2020to 4 Jan 2021
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

Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Weight:
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent

Who cannot join

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). A positive serology for hepatitis B surface antibody (HBsAb) as a result of Hepatitis B vaccination is allowed.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of allergy or hypersensitivity to fesoterodine fumarate or tolterodine tartrate, soya, or any of the excipients in the investigational drug product.
History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon.

Show all 18Show fewer

Evidence or history of clinically significant urologic disease: urinary retention, obstructive disturbance of bladder emptying, micturition disturbance, nocturia or pollakiuria (eg, benign prostate hyperplasia, urethral stricture, recurrent urinary tract infections).
Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of investigational product.
Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product used in this study (whichever is longer).
A positive urine drug test, as confirmed by a single repeat.
Screening supine blood pressure (BP) greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is greater than or equal to 140 mm Hg (systolic) or greater than or equal to 90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility.
Screening 12-lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block [LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree atrioventricular [AV] block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is greater than 450 msec, this interval should be rate-corrected using the Fridericia method and the resulting corrected QT (QTcF) should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer-interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants.
Participants with ANY of the following abnormalities in clinical laboratory tests at Screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary:
Screening estimated glomerular filtration rate (eGFR) is less than or equal to 90 mL /min/1.73 m2 for Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula).
History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine).
Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région de, B-1070

Other trials in Belgium

About this study

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, CROSSOVER STUDY TO ASSESS THE BIOEQUIVALENCE UNDER FED AND FASTED CONDITIONS OF FESOTERODINE BEADS-IN-CAPSULE SR7 AND SR4 FORMULATIONS, THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF THE BEADS-IN-CAPSULE SR7 FORMULATION AND TO ESTIMATE THE BIOAVAILABILITY OF SR7 BEADS SPRINKLED ON APPLE SAUCE RELATIVE TO THE BEADS-IN-CAPSULE SR7 FORMULATION ADMINISTERED INTACT

Read the detailed description

After oral administration, fesoterodine is not detected in plasma as it is rapidly and extensively hydrolyzed by non-specific esterases to its primary active metabolite 5-hydroxymethyl tolterodine (5-HMT) . Therefore characterization of the rate and extent of absorption of the test and reference fesoterodine formulations will be based on pharmacokinetic parameters of 5-HMT derived from the 5-HMT concentration-time profiles.

Conditions: Neurogenic Detrusor Overactivity
Being tested: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A), Fesoterodine BIC SR4 fed (Treatment E in Part B)
Keywords: Phase I, Fesoterodine beads- in-capsule, Bioequivalence, Pharmacokinetics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)Drug
4 mg administered under fasted condition.
Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)Drug
4 mg administered under fasted conditions.
Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)Drug
4 mg administered under fed conditions.
Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)Drug
4 mg sprinkled on apple sauce administered under fasting conditions
Fesoterodine BIC SR4 fed (Treatment E in Part B)Drug
4 mg administered under fed conditions

Study groups in NCT04452838
Study group	Role	What they receive
Cohort 1 Sequence 1 (Part A)	Other	Treatment Sequence A,B,C and D Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)
Cohort 1 Sequence 2 (Part A)	Other	Treatment Sequence B, A,C and D Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)
Cohort 2 Sequence 1 (Part B)	Other	Treatment Sequence E, F, G, and H Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)
Cohort 2 Sequence 2 (Part B)	Other	Treatment Sequence E, F, H and G Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)
Cohort 2 Sequence 3 (Part B)	Other	Treatment Sequence F, E, G, and H Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)
Cohort 2 Sequence 4 (Part B)	Other	Treatment sequence F, E, H, and G Receives: Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)

What is being measured

The primary outcome is the main question the study is designed to answer.

AUCinf of 5-HMT
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Measured: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
AUClast of 5-HMT
Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
Measured: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
Cmax of 5-HMT
Maximum Observed Plasma Concentration
Measured: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 20204 Jan 2021

First posted1 Jul 2020
Study start26 Jun 2020
Primary completion4 Jan 2021
Study completion4 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Neurogenic Detrusor OveractivityStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Model description: This is a Phase 1 randomized, open-label, single-dose crossover study in healthy participants. A two stage approach outlined below will be followed: Part A (Cohort 1): This part of the study is a 2 sequence, 4 period, crossover design. Part B (Cohort 2): This part of the study is a 4 sequence, 4 period, crossover design. Participants will be randomized to 1 of 4 possible treatment sequences. If bioequivalence (BE) criteria for the comparison of the BIC SR7 formulation with the BIC SR4 formulation administered in the fasted state are met in Part A, the formulations will be considered bioequivalent in the fasted state and only the first two periods of Part B will be conducted. Part B (all periods) may not be conducted if the AUCinf or Cmax Percent Geometric Mean Ratio GMR is less than 90% and greater than 111% and/or if variability suggest a highly variable drug (e.g., greater than 30%) because BE demonstration may not be possible with a reasonably sized 4 sequence 4 period study.
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04452838
Sponsor's protocol ID: A0221115
Other IDs: 2019-001909-24, 2019
Status last verified: Feb 2021
First submitted: 26 Jun 2020
Last updated: 10 Feb 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1, OPEN-LABEL, SINGLE-DOSE, CROSSOVER STUDY TO ASSESS THE BIOEQUIVALENCE UNDER FED AND FASTED CONDITIONS OF FESOTERODINE BEADS-IN-CAPSULE SR7 AND SR4 FORMULATIONS, THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF THE BEADS-IN-CAPSULE SR7 FORMULATION AND TO ESTIMATE THE BIOAVAILABILITY OF SR7 BEADS SPRINKLED ON APPLE SAUCE RELATIVE TO THE BEADS-IN-CAPSULE SR7 FORMULATION ADMINISTERED INTACT
ClinicalTrials.gov ID: NCT04452838
Acronym / sponsor ID: A0221115
Conditions: Neurogenic Detrusor Overactivity
Keywords: Phase I, Fesoterodine beads- in-capsule, Bioequivalence, Pharmacokinetics
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 26 Jun 2020 (actual)
Primary completion: 4 Jan 2021 (actual)
Study completion: 4 Jan 2021 (actual)
First posted: 1 Jul 2020 (actual)
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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6
Model description: This is a Phase 1 randomized, open-label, single-dose crossover study in healthy participants. A two stage approach outlined below will be followed: Part A (Cohort 1): This part of the study is a 2 sequence, 4 period, crossover design. Part B (Cohort 2): This part of the study is a 4 sequence, 4 period, crossover design. Participants will be randomized to 1 of 4 possible treatment sequences. If bioequivalence (BE) criteria for the comparison of the BIC SR7 formulation with the BIC SR4 formulation administered in the fasted state are met in Part A, the formulations will be considered bioequivalent in the fasted state and only the first two periods of Part B will be conducted. Part B (all periods) may not be conducted if the AUCinf or Cmax Percent Geometric Mean Ratio GMR is less than 90% and greater than 111% and/or if variability suggest a highly variable drug (e.g., greater than 30%) because BE demonstration may not be possible with a reasonably sized 4 sequence 4 period study.

Arm	Type	Receives
Cohort 1 Sequence 1 (Part A)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)Treatment Sequence A,B,C and D
Cohort 1 Sequence 2 (Part A)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)Treatment Sequence B, A,C and D
Cohort 2 Sequence 1 (Part B)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)Treatment Sequence E, F, G, and H
Cohort 2 Sequence 2 (Part B)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)Treatment Sequence E, F, H and G
Cohort 2 Sequence 3 (Part B)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)Treatment Sequence F, E, G, and H
Cohort 2 Sequence 4 (Part B)	Other	Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B), Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B), Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B), Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)Treatment sequence F, E, H, and G

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).
Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Weight:
Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).
Capable of giving signed informed consent

Key exclusion criteria (18 listed)

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibody (HCVAb). A positive serology for hepatitis B surface antibody (HBsAb) as a result of Hepatitis B vaccination is allowed.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
History of allergy or hypersensitivity to fesoterodine fumarate or tolterodine tartrate, soya, or any of the excipients in the investigational drug product.

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 BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)4 mg administered under fasted condition.	Drug	Cohort 1 Sequence 1 (Part A), Cohort 1 Sequence 2 (Part A), Cohort 2 Sequence 1 (Part B), Cohort 2 Sequence 2 (Part B), Cohort 2 Sequence 3 (Part B), Cohort 2 Sequence 4 (Part B)
Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)4 mg administered under fasted conditions.	Drug	Cohort 1 Sequence 1 (Part A), Cohort 1 Sequence 2 (Part A), Cohort 2 Sequence 1 (Part B), Cohort 2 Sequence 2 (Part B), Cohort 2 Sequence 3 (Part B), Cohort 2 Sequence 4 (Part B)
Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)4 mg administered under fed conditions.	Drug	Cohort 1 Sequence 1 (Part A), Cohort 1 Sequence 2 (Part A), Cohort 2 Sequence 1 (Part B), Cohort 2 Sequence 2 (Part B), Cohort 2 Sequence 3 (Part B), Cohort 2 Sequence 4 (Part B)
Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)4 mg sprinkled on apple sauce administered under fasting conditions	Drug	Cohort 1 Sequence 1 (Part A), Cohort 1 Sequence 2 (Part A)
Fesoterodine BIC SR4 fed (Treatment E in Part B)4 mg administered under fed conditions	Drug	Cohort 2 Sequence 1 (Part B), Cohort 2 Sequence 2 (Part B), Cohort 2 Sequence 3 (Part B), Cohort 2 Sequence 4 (Part B)

Primary outcome

AUCinf of 5-HMT
Time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
AUClast of 5-HMT
Time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
Cmax of 5-HMT
Time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours
Maximum Observed Plasma Concentration

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 10 Feb 2021.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

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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?

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 5 inclusion and 18 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 10 Feb 2021. 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?

AUCinf of 5-HMT (time frame: 0 (pre dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 30, 36, and 48 hours). 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?

On the ClinicalTrials.gov record for NCT04452838.

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 10 Feb 2021.