Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-20 @ 12:45 PM
Study NCT ID:
NCT02257151
Status:
COMPLETED
Last Update Posted:
2015-09-24
First Post:
2014-10-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2014-10-02', 'studyFirstSubmitQcDate': '2014-10-03', 'lastUpdatePostDateStruct': {'date': '2015-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142', 'timeFrame': 'Single Ascending Dose(SAD) within 8 days'}, {'measure': 'Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142', 'timeFrame': 'Multiple Ascending Dose (MAD) within 19 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volunteers'], 'conditions': ['Healthy Adult']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.', 'detailedDescription': 'Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/\\[height(m)\\]2\n\nExclusion Criteria:\n\n1. Any significant acute or chronic medical illness\n2. Current or recent (within 3 months of study drug administration) gastrointestinal disease\n3. Any major surgery within 4 weeks of study drug administration\n4. Any gastrointestinal surgery that could impact upon the absorption of study drug\n5. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)'}, 'identificationModule': {'nctId': 'NCT02257151', 'briefTitle': 'Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM006-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: BMS-986142 or placebo', 'description': 'BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified', 'interventionNames': ['Drug: BMS-986142', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: BMS-986142 or placebo', 'description': 'BMS-986142 or placebo Multiple dose oral Solution as specified', 'interventionNames': ['Drug: BMS-986142', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-986142', 'type': 'DRUG', 'armGroupLabels': ['Group 1: BMS-986142 or placebo', 'Group 2: BMS-986142 or placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Group 1: BMS-986142 or placebo', 'Group 2: BMS-986142 or placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Wcct Global, Llc', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}