Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01403818
Status:
COMPLETED
Last Update Posted:
2011-10-12
First Post:
2011-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-10', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-07-26', 'lastUpdatePostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics of ASP1941 and Mitiglinide calcium hydrate assessed by its plasma concentration change', 'timeFrame': 'For up to 72 hours after each administration'}], 'secondaryOutcomes': [{'measure': 'Safety assessed by incidence of adverse event, vital signs, 12-lead ECG and laboratory tests', 'timeFrame': 'For up to 10 days'}, {'measure': 'Pharmacokinetics of the metabolites of ASP1941 assessed by its plasma concentration change', 'timeFrame': 'For 72 hours after ASP1941 administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASP1941', 'ipragliflozin', 'Mitiglinide calcium hydrate', 'Drug-Drug interaction', 'Pharmacokinetics'], 'conditions': ['Healthy', 'Pharmacokinetics of ASP1941', 'Pharmacokinetics of Mitiglinide']}, 'descriptionModule': {'briefSummary': 'This study is to assess the pharmacokinetic interaction between ASP1941 and Mitiglinide calcium hydrate in healthy volunteers.', 'detailedDescription': 'This will be a randomized, open label, four group, two-way crossover design study to assess the effect of drug interaction between ASP1941 and Mitiglinide calcium hydrate on the pharmacokinetics of them after separate and concomitant administration to healthy non-elderly adult male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and laboratory tests\n* Body weight ; ≥50.0 kg, \\<80.0 kg\n* Body Mass Index ; ≥17.6, \\<26.4 kg/m2\n* Written informed consent has been obtained\n\nExclusion Criteria:\n\n* Received any investigational drugs within 120 days before the screening assessment\n* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or d components within 14 days before the screening assessment\n* Received medication within 7 days before hospital admission\n* A deviation from the assessment criteria of physical examinations or laboratory tests at screening or upon admission\n* History of drug allergies\n* With renal, hepatic, gastrointestinal, heart, cerebrovascular or respiratory diseases\n* Previous treatment with ASP1941'}, 'identificationModule': {'nctId': 'NCT01403818', 'briefTitle': 'A Study to Assess the Effect of ASP1941 and Mitiglinide on Their Plasma Concentration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Pharmacokinetic Study of ASP1941 -A Pharmacokinetic Study to Assess Drug-Drug Interaction Between ASP1941 and Mitiglinide Calcium Hydrate', 'orgStudyIdInfo': {'id': '1941-CL-0074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Subjects will receive "ASP1941 alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.', 'interventionNames': ['Drug: ASP1941', 'Drug: Mitiglinide calcium hydrate']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Subjects will receive "Mitiglinide calcium hydrate alone" and "ASP1941 + Mitiglinide calcium hydrate" in different orders.', 'interventionNames': ['Drug: ASP1941', 'Drug: Mitiglinide calcium hydrate']}], 'interventions': [{'name': 'ASP1941', 'type': 'DRUG', 'otherNames': ['ipragliflozin'], 'description': 'oral', 'armGroupLabels': ['Part 1', 'Part 2']}, {'name': 'Mitiglinide calcium hydrate', 'type': 'DRUG', 'otherNames': ['Glufast'], 'description': 'oral', 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kantou', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Use Central Contact', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}