Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-21 @ 11:36 PM
Study NCT ID:
NCT02262520
Status:
COMPLETED
Last Update Posted:
2015-08-10
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D004077', 'term': 'Digoxin'}], 'ancestors': [{'id': 'D004071', 'term': 'Digitalis Glycosides'}, {'id': 'D002298', 'term': 'Cardenolides'}, {'id': 'D002301', 'term': 'Cardiac Glycosides'}, {'id': 'D002297', 'term': 'Cardanolides'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-06', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2015-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apixaban and Digoxin plasma concentration', 'timeFrame': 'Days 8-21', 'description': 'Blood samples for Digoxin were collected on Days 8, 9, 10, 11, 18, 19, 20 \\& 21 Urine samples for Digoxin were collected for 24 hours post dose on Days 10 \\& 20. Blood samples for Apixaban concentration were collected on Days 18-20'}], 'secondaryOutcomes': [{'measure': 'Safety and Tolerability based on medical review of adverse event reports and the results of vital sign measurements, physical examinations, electrocardiograms, digoxin concentrations,and clinical laboratory tests', 'timeFrame': 'Days 1-22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['N/A - Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effects of Apixaban on the Pharmacokinetics (PK) of multiple-dose Digoxin in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECGs), and clinical laboratory determinations\n\nExclusion Criteria:\n\n• Any significant acute or chronic medical illness, history of important arrhythmias, history or evidence of abnormal bleeding or coagulation disorders, significant head injury within the last 2 years'}, 'identificationModule': {'nctId': 'NCT02262520', 'briefTitle': 'Phase 1 Drug Interaction Study of the Effect of Apixaban on the PK of Digoxin in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Effect of Apixaban on the Pharmacokinetics of Digoxin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CV185-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: Digoxin', 'description': 'Digoxin tablet by mouth on specified days', 'interventionNames': ['Drug: Digoxin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Apixaban and Digoxin', 'description': 'Apixaban and Digoxin tablets by mouth on specified days', 'interventionNames': ['Drug: Apixaban', 'Drug: Digoxin']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'armGroupLabels': ['Treatment B: Apixaban and Digoxin']}, {'name': 'Digoxin', 'type': 'DRUG', 'armGroupLabels': ['Treatment A: Digoxin', 'Treatment B: Apixaban and Digoxin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}