Back to resultsThe Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Primary Purpose
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fesoterodine
fesoterodine plus fluconazole
Sponsored by
About this trial
This is an interventional treatment trial for Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence focused on measuring The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects between the ages of 18 and 55 years
Exclusion Criteria:
- Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Fesoterodine Alone
fesoterodine plus fluconazole
Arm Description
Reference treatment
Test treatment
Outcomes
Primary Outcome Measures
AUCinf and Cmax of 5-HMT
Secondary Outcome Measures
AUClast, Tmax and half-life of 5-HMT as data permit.
Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00911235
Brief Title
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Official Title
An Open-Label, Randomized, Two-Way Crossover Study To Evaluate The Effect Of Fluconazole, A Moderate CYP3A4 Inhibitor, On The Single-Dose Pharmacokinetics Of Fesoterodine In Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence
Keywords
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fesoterodine Alone
Arm Type
Experimental
Arm Description
Reference treatment
Arm Title
fesoterodine plus fluconazole
Arm Type
Other
Arm Description
Test treatment
Intervention Type
Drug
Intervention Name(s)
Fesoterodine
Intervention Description
Single 8 mg oral dose of fesoterodine
Intervention Type
Drug
Intervention Name(s)
fesoterodine plus fluconazole
Intervention Description
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)
Primary Outcome Measure Information:
Title
AUCinf and Cmax of 5-HMT
Time Frame
3 days per period
Secondary Outcome Measure Information:
Title
AUClast, Tmax and half-life of 5-HMT as data permit.
Time Frame
3 days per period
Title
Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.
Time Frame
3 days per period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects between the ages of 18 and 55 years
Exclusion Criteria:
Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221080&StudyName=The%20Effect%20Of%20Fluconazole%20On%20Pharmacokinetics%20Of%20Fesoterodine%20In%20Healthy%20Subjects
Description
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Learn more about this trial
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
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