Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-28 @ 11:11 AM
Study NCT ID:
NCT03939702
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2019-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720754', 'term': 'milvexian'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2019-05-02', 'studyFirstSubmitQcDate': '2019-05-03', 'lastUpdatePostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess PK Cmax of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Cmax'}, {'measure': 'Assess PK AUC(INF) of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'AUC(INF)'}, {'measure': 'Assess PK AUC(0-T) of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'AUC(0-T)'}, {'measure': 'Assess PK Tmax of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Tmax'}, {'measure': 'Assess PK T-HALF of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'T-HALF'}, {'measure': 'Assess PK CL/F of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12'}, {'measure': 'Assess PK Vz/F of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Vz/F'}, {'measure': 'Assess PK AUC of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'AUC(BMS-986177)'}, {'measure': 'Assess PK AUC(TRA) of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'AUC(TRA)'}, {'measure': 'Assess PK Plasma AUC(TRA) of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Plasma AUC(TRA)'}, {'measure': 'Assess PK Blood AUC(TRA) of a dose of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Blood AUC(TRA)'}, {'measure': 'Assess the CLR of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'CLR'}, {'measure': 'Assess the %UR of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': '%UR'}, {'measure': 'Assess the %FE of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': '%FE'}, {'measure': 'Assess the %BE of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': '%BE (if applicable)'}, {'measure': 'Assess the %Total recovery of [14C]BMS-986177', 'timeFrame': 'Day 1-12', 'description': '%Total recovery'}], 'secondaryOutcomes': [{'measure': 'Asess the Incidence of AEs of a single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Incidence of AEs'}, {'measure': 'Asess the Incidence of SAEs of a single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Incidence of SAEs'}, {'measure': 'Asess the Incidence of AEs leading to discontinuation of a single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Incidence of AEs leading to discontinuation'}, {'measure': 'Assess the vital signs of a subject dosed with single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'results of vital sign examination'}, {'measure': 'Assess the ECGs of subjects dosed with single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'ECG physical examinations'}, {'measure': 'Assess the clinical lab tests of a single oral dose of 200 mg [14C] BMS-986177', 'timeFrame': 'Day 1-12', 'description': 'Results of Clinical laboratory tests'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis']}, 'descriptionModule': {'briefSummary': 'This is an ADME study. Human radiolabeled mass balance studies are performed as part of drug development to obtain information about the absorption, distribution, metabolism, and excretion (ADME) of a study treatment. The goals of human ADME studies include the assessment of absorption, distribution, routes and rates of excretion, mass balance, and metabolite profile and identification.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Born male', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed ICF\n* Healthy Male\n* Body mass index of 18.0 to 32.0 kg/m2, inclusive.\n* Agreement to use approved contraception for 94 days post treatment\n* Agreement to not donate sperm for 94 days post treatment\n\nExclusion Criteria:\n\n* Acute or chronic illness\n* GI disease current or recent\n* History of dizziness or recurring headaches\n* Head injury within last 2 years\n* GI surgery\n* History or evidence of abnormal bleeding'}, 'identificationModule': {'nctId': 'NCT03939702', 'briefTitle': 'Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pharmacokinetic and Metabolism of [14^C] BMS-986177 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'CV010-036'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Bile Collection', 'description': 'On Day 1, all participants will receive a single oral solution dose of 200 mg \\[14C\\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12', 'interventionNames': ['Drug: BMS-986177']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bile Collection', 'description': 'On Day 1, all participants will receive a single oral solution dose of 200 mg \\[14C\\] BMS-986177 containing approximately 88 micro Ci of total radioactivity (TRA). Approximately 1 hour after study drug administration, an ND tube may be positioned in approximately 3 selected participants for collection of bile.Participants will remain in the clinical facility until at least Day 7 and will be discharged when release criteria are met or until Day 12', 'interventionNames': ['Drug: BMS-986177']}], 'interventions': [{'name': 'BMS-986177', 'type': 'DRUG', 'description': 'An orally administered anticoagulant to prevent and treat thromboembolic events', 'armGroupLabels': ['Bile Collection', 'Non-Bile Collection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit, Inc.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}