Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-01-21 @ 11:36 AM
Study NCT ID:
NCT04269356
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2020-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008276', 'term': 'Magnesium Hydroxide'}], 'ancestors': [{'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D017616', 'term': 'Magnesium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-19', 'studyFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2020-02-12', 'lastUpdatePostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of [14C] BMS-986256', 'timeFrame': 'Up to 49 days'}, {'measure': 'Time to attain maximum observed plasma concentration (Tmax) of [14C] BMS-986256', 'timeFrame': 'Up to 49 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC (0-T)) of [14C] BMS-986256', 'timeFrame': 'Up to 49 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters', 'timeFrame': 'Up to 49 days'}, {'measure': 'Incidence of clinically significant changes in physical examination findings', 'timeFrame': 'Up to 49 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986856 in healthy males.', 'detailedDescription': 'Recruitment temporarily on hold due to COVID-19.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy participants, as determined by no clinically significant deviations from normal in medical history, physical examination abnormalities that would compromise the ability to participate, complete, and/or interpret the results of the study, 12-lead electrocardiograms (ECGs), vital signs, and clinical laboratory results.\n* Males must agree to follow specific methods of contraception, if applicable, while participating in the trial\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study\n* History of any significant drug and/or food allergies\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04269356', 'briefTitle': 'Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986256 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pharmacokinetics and Metabolism of a Single Dose of [14C] BMS-986256 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'IM026-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986256', 'interventionNames': ['Drug: BMS-986256', 'Drug: Milk of magnesia']}], 'interventions': [{'name': 'BMS-986256', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986256']}, {'name': 'Milk of magnesia', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986256']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance - Clinical Pharmacology Services - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}