Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-25 @ 8:02 PM
Study NCT ID:
NCT04882150
Status:
COMPLETED
Last Update Posted:
2023-01-12
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-11', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2023-01-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 24 days'}, {'measure': 'Severity of AEs', 'timeFrame': 'Up to 24 days'}, {'measure': 'Causality of AEs', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 59 days'}, {'measure': 'Severity of SAEs', 'timeFrame': 'Up to 59 days'}, {'measure': 'Causality of SAEs', 'timeFrame': 'Up to 59 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in weight', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in physical examination', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QT interval', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: HR', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Hematology tests', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Coagulation tests', 'timeFrame': 'Up to 24 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests', 'timeFrame': 'Up to 24 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy participants', 'BMS-986196'], '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 characterize the safety, tolerability, drug levels and drug effects of BMS-986196 in healthy participants. In addition, an evaluation of food and formulation effects on BMS-986196 absorption will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women not of childbearing potential and men, ages 18 or local age of majority to 55 years, inclusive\n* Healthy male and female non-Japanese participants without clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations\n* Body mass index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg\n\nExclusion Criteria:\n\n* Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet's disease, dermatomyositis, MS, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a participant requires medical follow-up or medical treatment\n* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status\n* Presence of any factors that would predispose the participant to develop infection\n* A history of bacterial or fungal meningitis within 1 year prior to screening\n* A history of intracranial or intraspinal bleeding\n* Known intracranial space-occupying mass, including meningioma\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04882150', 'briefTitle': 'A Study to Determine the Safety, Drug Levels and Drug Effects of BMS-986196 and Food and Formulation Effects on Relative Absorption Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986196 in Healthy Participants Including an Open-label Assessment of Food and Formulation Effects on the Relative Bioavailability of BMS-986196', 'orgStudyIdInfo': {'id': 'IM038-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: SAD', 'description': 'SAD = single ascending dose. Each participant will receive a single dose of BMS-986196 or placebo.', 'interventionNames': ['Drug: BMS-986196', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: MAD', 'description': 'MAD = multiple ascending dose. Each participant will receive multiple doses of BMS-986196 or placebo.', 'interventionNames': ['Drug: BMS-986196', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: FE/Formul.', 'description': 'FE/Formul. = food and formulation effects and relative absorption. Participants will receive two formulations of BMS-986196 (solution and suspension), each formulation with and without food.', 'interventionNames': ['Drug: BMS-986196']}], 'interventions': [{'name': 'BMS-986196', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: SAD', 'Part B: MAD', 'Part C: FE/Formul.']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: SAD', 'Part B: MAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}