NCT01566760

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2012

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 19, 2016

Status Verified

July 1, 2012

Enrollment Period

2 months

First QC Date

March 27, 2012

Last Update Submit

August 17, 2016

Conditions

Urinary Bladder, Overactive

Keywords

food effectbioavailabilitypharmacokineticsfesoterodine5-hydroxymethyl tolterodinetreatment of overactive bladder

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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.

Study Arms (5)

Treatment A, Cohort 1

EXPERIMENTAL
Drug: fesoterodine fumarate

Treatment B, Cohort 2

EXPERIMENTAL
Drug: fesoterodine fumarate

Treatment C, Cohort 1

EXPERIMENTAL
Drug: fesoterodine fumarate

Treatment D, Cohort 2

EXPERIMENTAL
Drug: fesoterodine fumarate

Treatment E, Cohort 1 and/or Cohort 2

ACTIVE COMPARATOR
Drug: fesoterodine fumarate

Interventions

fesoterodine fumarateDRUG

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

Treatment A, Cohort 1

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and/or female subjects between 21 and 55 years of age(inclusive).

You may not qualify if:

  • Evidence or history of clinically significant disease.
  • Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Singapore, Singapore, 188770, Singapore

Location

Related Links

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2012

First Posted

March 29, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 19, 2016

Record last verified: 2012-07

Locations

SG(1)