Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-16 @ 11:12 PM
Study NCT ID:
NCT02531568
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2015-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study of Warfarin and MT-3995
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014859', 'term': 'Warfarin'}, {'id': 'C000719999', 'term': 'apararenone'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-07', 'studyFirstSubmitDate': '2015-08-04', 'studyFirstSubmitQcDate': '2015-08-20', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of warfarin with MT-3995 versus warfarin alone', 'timeFrame': '8 days'}, {'measure': 'AUC of warfarin with MT-3995 versus warfarin alone', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'International normalized ratio (INR) max of warfarin with MT-3995 versus warfarin alone', 'timeFrame': '8 days'}, {'measure': 'INR AUC of warfarin with MT-3995 versus warfarin alone', 'timeFrame': '8 days'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33153727', 'type': 'DERIVED', 'citation': 'Nakamura T, Shimizu H, Kawaguchi A. Drug-Drug Interactions of the Nonsteroidal Mineralocorticoid Receptor Antagonist Apararenone With Midazolam, Warfarin, and Digoxin: A Phase 1 Studies in Healthy Volunteers. Clin Ther. 2020 Nov;42(11):2171-2183.e4. doi: 10.1016/j.clinthera.2020.09.002. Epub 2020 Nov 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effects of MT-3995 on the PK of warfarin', 'detailedDescription': 'The purpose of this study is to evaluate the potential effects of multiple once daily doses of MT-3995 on the PK of (S)-warfarin and (R)-warfarin after single-dose administration of racemic warfarin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able and willing to provide written informed consent to participate in this study\n* Healthy, free from clinically significant illness or disease\n* White Caucasian male or female, aged 18 to 55 years\n* Body weight ranging from 50 (females) and 60 (males) to110 kg (inclusive)\n* Must have coagulation test results (including international normalised ratio \\[INR\\] and activated partial thromboplastin time \\[aPTT\\]) within the laboratory reference range at Screening.\n\nExclusion Criteria:\n\n* Presence or history of serious adverse reaction or allergy to any medicinal product\n* Known contraindication or adverse reaction to warfarin.\n* Presence of Cytochrome P450 2C9 (CYP2C9) and Vitamin K epoxide reductase complex subunit 1 (VKORC1) genetic polymorphisms that are known to increase warfarin sensitivity at Screening.\n* Known contraindications to heparin administration.\n* Known contraindication to parenteral vitamin K administration.'}, 'identificationModule': {'nctId': 'NCT02531568', 'briefTitle': 'Drug Interaction Study of Warfarin and MT-3995', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase I, Open-label, Single-Centre, Drug-Drug Interaction Study to Evaluate the Influence of MT-3995 on Pharmacokinetics(PK) and Pharmacodynamics of Warfarin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MT-3995-E10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Warfarin and MT-3995', 'description': 'Subjects will be administered a single dose of warfarin on day1. Subjects will be administered MT-3995 Days 8 to 20. Subjects will be administered MT-3995 and warfarin on Day21. Subjects will be administered MT-3995 from Day 22 to 27.', 'interventionNames': ['Drug: Warfarin', 'Drug: MT-3995']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'armGroupLabels': ['Warfarin and MT-3995']}, {'name': 'MT-3995', 'type': 'DRUG', 'armGroupLabels': ['Warfarin and MT-3995']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Neu-Ulm', 'state': 'Wegenerstraße', 'country': 'Germany', 'facility': 'Clinical research organization', 'geoPoint': {'lat': 48.39279, 'lon': 10.01112}}], 'overallOfficials': [{'name': 'Horst Heuer, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nuvisan GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}