Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 5:54 AM
Study NCT ID:
NCT01566760
Status:
COMPLETED
Last Update Posted:
2016-08-19
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053201', 'term': 'Urinary Bladder, Overactive'}], 'ancestors': [{'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-17', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-27', 'lastUpdatePostDateStruct': {'date': '2016-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)]', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 15, 24, 30, 36, and 48 hours post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['food effect', 'bioavailability', 'pharmacokinetics', 'fesoterodine', '5-hydroxymethyl tolterodine', 'treatment of overactive bladder'], 'conditions': ['Urinary Bladder, Overactive']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221069', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female subjects between 21 and 55 years of age(inclusive).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease.\n* Evidence or history of urologic disease (benign prostate hyperplasia, recurrent urinary tract infections, urinary retention, etc.).'}, 'identificationModule': {'nctId': 'NCT01566760', 'briefTitle': 'A Study To Estimate The Effects Of Food On Drug Fesoterodine Fumarate And The Pharmacokinetics Of 5-Hydroxymethyl Tolterodine (5-HMT) In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Open-Label, Single-Dose, Randomized, Crossover Study To Estimate The Effects Of Food On The Pharmacokinetics Of Two Fesoterodine Sustained-Release Beads-In-Capsule Formulations And To Estimate The Relative Bioavailability Of One Or Both Formulations Compared To Commercial Tablet Formulation In Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'A0221069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A, Cohort 1', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B, Cohort 2', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C, Cohort 1', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D, Cohort 2', 'interventionNames': ['Drug: fesoterodine fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment E, Cohort 1 and/or Cohort 2', 'interventionNames': ['Drug: fesoterodine fumarate']}], 'interventions': [{'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': 'One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose', 'armGroupLabels': ['Treatment A, Cohort 1']}, {'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': 'One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose', 'armGroupLabels': ['Treatment B, Cohort 2']}, {'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': 'One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose', 'armGroupLabels': ['Treatment C, Cohort 1']}, {'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': 'One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose', 'armGroupLabels': ['Treatment D, Cohort 2']}, {'name': 'fesoterodine fumarate', 'type': 'DRUG', 'description': 'one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose', 'armGroupLabels': ['Treatment E, Cohort 1 and/or Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}