Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-03 @ 4:41 AM
Study NCT ID:
NCT01302158
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2011-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-drug Interaction Study With ASP1941 and Glimepiride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C572941', 'term': 'ipragliflozin'}, {'id': 'C057619', 'term': 'glimepiride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-04', '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': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of multiple doses of ASP1941 on the Pharmacokinetics of glimepiride', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Effect of multiple doses of glimepiride on the Pharmacokinetics of ASP1941', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-Drug interaction', 'ASP1941', 'Glimepiride', 'Healthy subjects'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'A study to investigate the effect of ASP1941 on the pharmacokinetics and safety of glimepiride (Part A) and to investigate the effect of glimepiride on the pharmacokinetics, safety and pharmacodynamics of ASP1941 (Part B).', 'detailedDescription': 'Study includes two parts. Part A is to investigate the effect of multiple oral doses of ASP1941 on the pharmacokinetics of glimepiride, and Part B is to investigate the effect of multiple oral doses of glimepiride on the pharmacokinetics of ASP1941.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18.5 and 30 kg/m2, inclusive\n\nExclusion Criteria:\n\n* Any of the liver function tests above the upper limit of normal\n* Pulse \\<40 or \\>90 bpm; Systolic Blood Pressure \\>140 mmHg; Diastolic Blood Pressure \\> 90 mmHg'}, 'identificationModule': {'nctId': 'NCT01302158', 'briefTitle': 'Drug-drug Interaction Study With ASP1941 and Glimepiride', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'An Open-label, Randomized Crossover Study to Evaluate the Effect of ASP1941 on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Glimepiride in Healthy Subjects and Vice Versa', 'orgStudyIdInfo': {'id': '1941-CL-0059'}, 'secondaryIdInfos': [{'id': '2009-013172-50', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'description': 'oral'}, {'name': 'Glimepiride', 'type': 'DRUG', 'description': 'oral'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9470 AE', 'city': 'Groningen', 'country': 'Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], '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'}}}}