Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Fesoterodine BIC SR7 fed, Fesoterodine BIC SR4 fed
Fesoterodine BIC SR4 · 1 trial · 1 indication
Area under the plasma concentration-time curve from time zero extrapolated to infinity.
Area under the plasma concentration-time curve from 0 to the time of the last quantifiable concentration.
Maximum Observed Plasma Concentration
| Arm | Type | Description |
|---|---|---|
| Cohort 1 Sequence 1 (Part A) | OTHER | Treatment Sequence A,B,C and D |
| Cohort 1 Sequence 2 (Part A) | OTHER | Treatment Sequence B, A,C and D |
| Cohort 2 Sequence 1 (Part B) | OTHER | Treatment Sequence E, F, G, and H |
| Cohort 2 Sequence 2 (Part B) | OTHER | Treatment Sequence E, F, H and G |
| Cohort 2 Sequence 3 (Part B) | OTHER | Treatment Sequence F, E, G, and H |
| Cohort 2 Sequence 4 (Part B) | OTHER | Treatment sequence F, E, H, and G |
| Name | Type | Description |
|---|---|---|
| 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 |
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...
Fesoterodine BIC SR4 is an investigational small molecule formulation of fesoterodine, developed by Pfizer, Inc. (PFE), for neurogenic detrusor overactivity. It is a beads-in-capsule sustained-release formulation studied in a Phase 1 clinical trial. The drug is not approved and remains in clinical development.
Fesoterodine BIC SR4 targets CHRM2 and CHRM3, which are muscarinic acetylcholine receptors. It acts as an antagonist at these receptors. By blocking these targets, it is intended to reduce bladder contractions in neurogenic detrusor overactivity.
Fesoterodine BIC SR4 is being developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the sponsor of the clinical program for this formulation.
Fesoterodine BIC SR4 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any regulatory agency. The only listed trial for this formulation is completed.
Fesoterodine BIC SR4 has been studied in one completed Phase 1 trial, NCT04452838. This trial assessed bioequivalence under fed and fasted conditions of the SR4 and SR7 beads-in-capsule formulations and estimated bioavailability of SR7 beads sprinkled on apple sauce. It enrolled 37 participants in Belgium.
No, Fesoterodine BIC SR4 and Fesoterodine BIC SR7 are different sustained-release formulations. SR4 and SR7 refer to distinct beads-in-capsule versions. Both were evaluated in the same Phase 1 trial, NCT04452838, under fed and fasted conditions.