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Fesoterodine BIC SR4

Phase 1

Neurogenic Detrusor Overactivity | Small molecule | Urology |Pfizer, Inc.|Last Updated: Feb 10, 2021

Target and mechanism

ModalitySmall molecule

Also known as Fesoterodine BIC SR4 fasted, Fesoterodine BIC SR7 fasted, Fesoterodine BIC SR7 fed, Fesoterodine BIC SR4 fed (Treatment E in Part B), Fesoterodine BIC SR4 fed

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

Fesoterodine BIC SR4 · 1 trial · 1 indication

Phase 1 1
NCT04452838Study 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 AdministerNeurogenic Detrusor Overactivity
COMPLETED37 Analytics
PHASE1COMPLETED
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
Neurogenic Detrusor OveractivityUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Maximum Observed Plasma Concentration

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
Cohort 1 Sequence 1 (Part A)OTHERTreatment Sequence A,B,C and D
Cohort 1 Sequence 2 (Part A)OTHERTreatment Sequence B, A,C and D
Cohort 2 Sequence 1 (Part B)OTHERTreatment Sequence E, F, G, and H
Cohort 2 Sequence 2 (Part B)OTHERTreatment Sequence E, F, H and G
Cohort 2 Sequence 3 (Part B)OTHERTreatment Sequence F, E, G, and H
Cohort 2 Sequence 4 (Part B)OTHERTreatment sequence F, E, H, and G

Interventions

NameTypeDescription
Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)DRUG4 mg administered under fasted condition.
Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)DRUG4 mg administered under fasted conditions.
Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)DRUG4 mg administered under fed conditions.
Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)DRUG4 mg sprinkled on apple sauce administered under fasting conditions
Fesoterodine BIC SR4 fed (Treatment E in Part B)DRUG4 mg administered under fed conditions
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 l...

Countries:Belgium
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