A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers

Study Overview
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Brief Summary
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This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 2-cohort, 3-period study to characterize the pharmacokinetics (process by which drug fesoterodine is absorbed, distributed, metabolized, and eliminated by the body) and the effects of food on the pharmacokinetics of the drug. This study will take place over approximately 8 weeks and will consist of a screening visit to determine eligibility for the study, and 2- or 3-period treatment phase for each cohort.

Official Title
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Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: fesoterodine fumarate
* Drug: fesoterodine fumarate
* Drug: fesoterodine fumarate
* Drug: fesoterodine fumarate
* Drug: fesoterodine fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between 21 and 55 years of age(inclusive). Exclusion Criteria: Evidence or history of clinically significant disease. Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A, Cohort 1<br> | Drug: fesoterodine fumarate<br>* One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose<br>|
| Experimental: Treatment B, Cohort 2<br> | Drug: fesoterodine fumarate<br>* One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose<br>|
| Experimental: Treatment C, Cohort 1<br> | Drug: fesoterodine fumarate<br>* One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose<br>|
| Experimental: Treatment D, Cohort 2<br> | Drug: fesoterodine fumarate<br>* One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose<br>|
| Active Comparator: Treatment E, Cohort 1 and/or Cohort 2<br> | Drug: fesoterodine fumarate<br>* one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | 
| Plasma Decay Half-Life (t1/2) |  | 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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5-hydroxymethyl tolterodine, treatment of overactive bladder, food effect, bioavailability, pharmacokinetics, fesoterodine