Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-30 @ 6:45 PM
Study NCT ID:
NCT01302132
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of ASP1941
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C572941', 'term': 'ipragliflozin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-21', 'studyFirstSubmitDate': '2011-02-21', 'studyFirstSubmitQcDate': '2011-02-21', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of ASP1941 to evaluate metabolism and excretion', 'timeFrame': 'up to 216 hours'}], 'secondaryOutcomes': [{'measure': 'Identification of metabolic profile of ASP1941', 'timeFrame': 'up to 216 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mass Balance', 'ASP1941', 'Pharmacokinetics'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This study investigates the pharmacokinetics, in particular the routes and extent of metabolism and excretion, of ASP1941 after a single oral dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight between 60-100kg, BMI between 18.5-30 kg/m2, inclusive\n\nExclusion Criteria:\n\n* Pulse \\<40 or \\>90 bpm; Systolic Blood Pressure \\> 140 mmHg; Diastolic Blood Pressure \\>90 mmHg'}, 'identificationModule': {'nctId': 'NCT01302132', 'briefTitle': 'Mass Balance Study of ASP1941', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open Label Study to Evaluate the Pharmacokinetics of ASP1941 After a Single Oral Dose of 14C-labeled ASP1941 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '1941-CL-0055'}, 'secondaryIdInfos': [{'id': '2008-000316-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'description': 'Oral solution'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9470 AE', 'city': 'Zuidlaren', 'country': 'Netherlands', 'geoPoint': {'lat': 53.09417, 'lon': 6.68194}}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Disclosure Office Europe', 'oldOrganization': 'Astellas Pharma Europe BV'}}}}