NCT00911235

Brief Summary

This study is designed to estimate the effect of fluconazole (200 mg BID for 2 days), a moderate CYP3A4 inhibitor on the pharmacokinetics of a single 8 mg oral dose of fesoterodine in healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2009

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 1, 2011

Status Verified

May 1, 2011

Enrollment Period

2 months

First QC Date

May 28, 2009

Last Update Submit

May 31, 2011

Conditions

Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence

Keywords

The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • AUCinf and Cmax of 5-HMT

    3 days per period

Secondary Outcomes (2)

  • AUClast, Tmax and half-life of 5-HMT as data permit.

    3 days per period

  • Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.

    3 days per period

Study Arms (2)

Fesoterodine Alone

EXPERIMENTAL

Reference treatment

Drug: Fesoterodine

fesoterodine plus fluconazole

OTHER

Test treatment

Drug: fesoterodine plus fluconazole

Interventions

FesoterodineDRUG

Single 8 mg oral dose of fesoterodine

Fesoterodine Alone
fesoterodine plus fluconazoleDRUG

On Day 1, fluconazole (200 mg oral dose) will be given 1 hour before and approximately 11 hour following a single 8 mg oral dose of fesoterodine (fesoterodine SD). Fluconazole will also be administered 200 mg BID on the Day 2 (ie, at approximately 24 and 36 hours following the fesoterodine SD treatment given on Day 1)

fesoterodine plus fluconazole

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects between the ages of 18 and 55 years

You may not qualify if:

  • Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Urinary Incontinence, Urge

Interventions

fesoterodineFluconazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

May 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 1, 2011

Record last verified: 2011-05

Locations

US(1)