Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT00911235
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2009-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053202', 'term': 'Urinary Incontinence, Urge'}], 'ancestors': [{'id': 'D014549', 'term': 'Urinary Incontinence'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D059411', 'term': 'Lower Urinary Tract Symptoms'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C526675', 'term': 'fesoterodine'}, {'id': 'D015725', 'term': 'Fluconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-31', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf and Cmax of 5-HMT', 'timeFrame': '3 days per period'}], 'secondaryOutcomes': [{'measure': 'AUClast, Tmax and half-life of 5-HMT as data permit.', 'timeFrame': '3 days per period'}, {'measure': 'Safety will be assessed by subjective symptoms/objective findings including physical examination findings, clinical safety laboratory assessments and adverse event monitoring.', 'timeFrame': '3 days per period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects'], 'conditions': ['Overactive Bladder With Symptoms of Frequency, Urgency, and Urge Urinary Incontinence']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects between the ages of 18 and 55 years\n\nExclusion Criteria:\n\n* Not healthy subjects. subjects with acute or chronic medical or psychiatric condition or laboratory abnormality'}, 'identificationModule': {'nctId': 'NCT00911235', 'briefTitle': 'The Effect Of Fluconazole On Pharmacokinetics Of Fesoterodine In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'A0221080'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fesoterodine Alone', 'description': 'Reference treatment', 'interventionNames': ['Drug: Fesoterodine']}, {'type': 'OTHER', 'label': 'fesoterodine plus fluconazole', 'description': 'Test treatment', 'interventionNames': ['Drug: fesoterodine plus fluconazole']}], 'interventions': [{'name': 'Fesoterodine', 'type': 'DRUG', 'description': 'Single 8 mg oral dose of fesoterodine', 'armGroupLabels': ['Fesoterodine Alone']}, {'name': 'fesoterodine plus fluconazole', 'type': 'DRUG', '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)', 'armGroupLabels': ['fesoterodine plus fluconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}