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

NCT04452838

Last updated date
Study Location
Brussels Clinical Research Unit
Brussels, Bruxelles-capitale, Région DE, B-1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neurogenic Detrusor Overactivity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Male and female participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (ICD).

2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.

3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Weight:

4. Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

5. Capable of giving signed informed consent

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


1. 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).


2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).


3. 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.


4. 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.


5. History of allergy or hypersensitivity to fesoterodine fumarate or tolterodine
tartrate, soya, or any of the excipients in the investigational drug product.


6. History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention,
severe ulcerative colitis and toxic megacolon.


7. 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).


8. 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.


9. 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).


10. A positive urine drug test, as confirmed by a single repeat.


11. 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.


12. 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.


13. 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:


14. 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).


15. 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).


16. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.


17. Unwilling or unable to comply with the criteria in the Lifestyle Considerations
section of this protocol.


18. 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.

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Other
Condition  ICMJE Neurogenic Detrusor Overactivity
Intervention  ICMJE
  • Drug: Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)
    4 mg administered under fasted condition.
  • Drug: Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)
    4 mg administered under fasted conditions.
  • Drug: Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)
    4 mg administered under fed conditions.
  • Drug: Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)
    4 mg sprinkled on apple sauce administered under fasting conditions
  • Drug: Fesoterodine BIC SR4 fed (Treatment E in Part B)
    4 mg administered under fed conditions
Study Arms  ICMJE
  • Cohort 1 Sequence 1 (Part A)
    Treatment Sequence A,B,C and D
    Interventions:
    • 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)
    Treatment Sequence B, A,C and D
    Interventions:
    • 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)
    Treatment Sequence E, F, G, and H
    Interventions:
    • 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)
    Treatment Sequence E, F, H and G
    Interventions:
    • 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)
    Treatment Sequence F, E, G, and H
    Interventions:
    • 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)
    Treatment sequence F, E, H, and G
    Interventions:
    • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 26, 2020)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 18, 2021
Estimated Primary Completion Date March 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

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

Exclusion Criteria:

  1. 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).
  2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  3. 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.
  4. 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.
  5. History of allergy or hypersensitivity to fesoterodine fumarate or tolterodine tartrate, soya, or any of the excipients in the investigational drug product.
  6. History of uncontrolled narrow angle glaucoma, myasthenia gravis, gastric retention, severe ulcerative colitis and toxic megacolon.
  7. 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).
  8. 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.
  9. 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).
  10. A positive urine drug test, as confirmed by a single repeat.
  11. 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.
  12. 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.
  13. 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:
  14. 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).
  15. 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).
  16. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing.
  17. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol.
  18. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04452838
Other Study ID Numbers  ICMJE A0221115
2019-001909-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP