Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT03004768
Status:
COMPLETED
Last Update Posted:
2018-02-12
First Post:
2016-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-08', 'studyFirstSubmitDate': '2016-12-19', 'studyFirstSubmitQcDate': '2016-12-23', 'lastUpdatePostDateStruct': {'date': '2018-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is PK exposure that will be determined from plasma concentration versus time', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Urinary/fecal TRA (Total radioactivity) recovery data', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'PK terminal elimination half-life data (T-HALF)', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'PK apparent total body clearance (CL/F)', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'PK apparent volume of distribution (Vz/F)', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'PK time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Day 1 to Day 13'}], 'secondaryOutcomes': [{'measure': 'Safety endpoints include the incidence of adverse events (AEs)', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety endpoints include the results of electrocardiogram tests (ECGs)', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety endpoints include the results of vital signs', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety endpoints include the results of physical exams', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety endpoints include the results of clinical laboratory tests', 'timeFrame': 'Day 1 to Day 13'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriasis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/pages/home.aspx', 'label': 'BMS Clinical Trial Education Resource'}, {'url': 'http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}, {'url': 'http://www.fda.gov/Safety/Recalls/', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'An oral dose in healthy subjects to obtain information about the absorption, metabolism, and excretion (AME) of BMS-986165'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Informed Consent\n* Target population: Healthy males with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ECGs), physical measurements, and clinical laboratory tests\n* Body weight of at least 50 kilograms (110 pounds); body mass index (BMI) between 18 to 32 kg/m2.\n* No evidence of acute infection or other significant problem as determined from a review of a chest x-ray, medical history, and physical examination\n\nExclusion Criteria:\n\n* History of any chronic or acute illness including active TB in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured.\n* Vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population.\n* Participant with greater than Grade 2 acne.\n* Participated in a radiolabeled drug study within the previous 12 months; clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months; or current employment in a job requiring radiation exposure monitoring.'}, 'identificationModule': {'nctId': 'NCT03004768', 'briefTitle': 'Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male Participants', 'orgStudyIdInfo': {'id': 'IM011-016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single dose of radiolabeled BMS-986165', 'interventionNames': ['Drug: BMS-986165']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Oral solution dose of 24 mg \\[14C\\] BMS-986165 containing approximately 100 micro Ci of TRA', 'armGroupLabels': ['Single dose of radiolabeled BMS-986165']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Madison Clinical Research Unit', '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'}, 'collaborators': [{'name': 'Covance', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}