Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-26 @ 12:29 PM
Study NCT ID:
NCT05409157
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2022-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706608', 'term': 'BMS-986166'}, {'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2022-06-03', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total amount of total radioactivity (TRA) recovered in urine (UR)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Total amount of TRA recovered in feces (FR)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Total amount of TRA recovered in urine and feces combined (RTotal)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Percent of TRA recovered in urine (%UR)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Percent of TRA recovered in feces (%FR)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Percent of TRA recovered in urine and feces combined (%TOTAL)', 'timeFrame': 'Up to 90 days'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to 89 days'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to 89 days'}, {'measure': 'Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 89 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 124 days'}, {'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 124 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 90 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 90 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 90 days'}, {'measure': 'Number of participants with clinical laboratory test abnormalities', 'timeFrame': 'Up to 90 days'}, {'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to 89 days'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to 89 days'}, {'measure': 'Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 89 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'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations\n* Body mass index between 18.0 to 33.0 kg/m2 (inclusive)\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)\n* History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT05409157', 'briefTitle': 'A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'IM018-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group 1: BMS-986166', 'interventionNames': ['Drug: BMS-986166', 'Drug: Bisacodyl']}], 'interventions': [{'name': 'BMS-986166', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Treatment Group 1: BMS-986166']}, {'name': 'Bisacodyl', 'type': 'DRUG', 'otherNames': ['Dulcolax®'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Treatment Group 1: BMS-986166']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704-2526', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Local Institution - 0001', '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'}}}}