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

Primary Purpose

Urinary Bladder, Overactive

Status

Completed

Phase

Phase 1

Locations

Singapore

Study Type

Interventional

Intervention

fesoterodine fumarate

About this trial

This is an interventional basic science trial for Urinary Bladder, Overactive focused on measuring food effect, bioavailability, pharmacokinetics, fesoterodine, 5-hydroxymethyl tolterodine, treatment of overactive bladder

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts 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.).

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Treatment A, Cohort 1

Treatment B, Cohort 2

Treatment C, Cohort 1

Treatment D, Cohort 2

Treatment E, Cohort 1 and/or Cohort 2

Arm Description

Outcomes

Primary Outcome Measures

Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]

Maximum Observed Plasma Concentration (Cmax)

Secondary Outcome Measures

Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

Full Information

NCT ID

NCT01566760

First Posted

March 27, 2012

Last Updated

August 17, 2016

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01566760

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Overactive

Keywords

food effect, bioavailability, pharmacokinetics, fesoterodine, 5-hydroxymethyl tolterodine, treatment of overactive bladder

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A, Cohort 1

Arm Type

Experimental

Arm Title

Treatment B, Cohort 2

Arm Type

Experimental

Arm Title

Treatment C, Cohort 1

Arm Type

Experimental

Arm Title

Treatment D, Cohort 2

Arm Type

Experimental

Arm Title

Treatment E, Cohort 1 and/or Cohort 2

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

fesoterodine fumarate

Intervention Description

One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose

Intervention Type

Drug

Intervention Name(s)

fesoterodine fumarate

Intervention Description

One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose

Intervention Type

Drug

Intervention Name(s)

fesoterodine fumarate

Intervention Description

One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose

Intervention Type

Drug

Intervention Name(s)

fesoterodine fumarate

Intervention Description

One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose

Intervention Type

Drug

Intervention Name(s)

fesoterodine fumarate

Intervention Description

one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose

Primary Outcome Measure Information:

Title

Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]

Time Frame