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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder, Overactive

Treatments: Drug: fesoterodine fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01566760

A0221069

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 5 patient groups

Treatment A, Cohort 1

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Treatment B, Cohort 2

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Treatment C, Cohort 1

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Treatment D, Cohort 2

Experimental group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Treatment E, Cohort 1 and/or Cohort 2

Active Comparator group

Treatment:

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate

Drug: fesoterodine fumarate