Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-26 @ 1:36 PM
Study NCT ID:
NCT04567667
Status:
COMPLETED
Last Update Posted:
2022-06-02
First Post:
2020-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012844', 'term': 'Sincalide'}], 'ancestors': [{'id': 'D002766', 'term': 'Cholecystokinin'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986278', 'timeFrame': 'Up to 15 days'}, {'measure': 'Maximum observed plasma concentration (Cmax) of total radioactivity (TRA)', 'timeFrame': 'Up to 15 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-986278', 'timeFrame': 'Up to 15 days'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of TRA', 'timeFrame': 'Up to 15 days'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278', 'timeFrame': 'Up to 15 days'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA', 'timeFrame': 'Up to 15 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 15 days'}, {'measure': 'Incidence of Serious Adverse Events (AEs)', 'timeFrame': 'Up to 73 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 43 days'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF', 'timeFrame': 'Up to 43 days', 'description': 'QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval', 'timeFrame': 'Up to 43 days', 'description': 'The QT interval is the time from the start of the Q wave to the end of the T wave.'}, {'measure': 'Incidence of clinically significant changes in physical examination findings', 'timeFrame': 'Up to 43 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy Volunteers']}, '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-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations\n* Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height \\[m\\])2\n* Males must agree to follow specific methods of contraception, if applicable\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, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome\n* Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment\n* Any major surgery within 6 weeks of study treatment administration\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04567667', 'briefTitle': 'Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'IM027-048'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: [14C] BMS-986278']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Drug: [14C] BMS-986278', 'Drug: Kinevac®']}], 'interventions': [{'name': '[14C] BMS-986278', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Kinevac®', 'type': 'DRUG', 'otherNames': ['Sincalide'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group 2']}]}, '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'}}}}