The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00911235
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 2
• Patients Per Site Per Month: 14

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence	Drug: Fesoterodine; Drug: fesoterodine plus fluconazole	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2009
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fesoterodine Alone Reference treatment	Drug: Fesoterodine; Single 8 mg oral dose of fesoterodine
Other: fesoterodine plus fluconazole Test treatment	Drug: fesoterodine plus fluconazole; 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)

Outcome Measures

Primary Outcome Measures

1. AUCinf and Cmax of 5-HMT [3 days per period]

Secondary Outcome Measures

1. AUClast, Tmax and half-life of 5-HMT as data permit. [3 days per period]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	New Haven	Connecticut	United States	06511

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00911235
• Other Study ID Numbers: A0221080
• First Posted: Jun 1, 2009
• Last Update Posted: Jun 1, 2011
• Last Verified: May 1, 2011

• Keywords provided by , ,: The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
• Additional relevant MeSH terms: Urinary Incontinence; Urinary Bladder, Overactive; Urinary Incontinence, Urge; Fluconazole; Fesoterodine

Study Results

No Results Posted as of Jun 1, 2011