Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT04965402
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2021-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706608', 'term': 'BMS-986166'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2021-07-07', 'lastUpdatePostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)', 'timeFrame': 'Day 1, Day 28'}, {'measure': 'PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)', 'timeFrame': 'Day 1, Day 28'}, {'measure': 'PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))', 'timeFrame': 'Day 1, Day 28'}, {'measure': 'PK parameters of BMT-121795: Cmax', 'timeFrame': 'Day 1, Day 28'}, {'measure': 'PK parameters of BMT-121795: Tmax', 'timeFrame': 'Day 1, Day 28'}, {'measure': 'PK parameters of BMT-121795: AUC(TAU)', 'timeFrame': 'Day 1, Day 28'}], 'secondaryOutcomes': [{'measure': 'Incidence of all adverse events (AEs)', 'timeFrame': 'Up to 77 days'}, {'measure': 'Severity of all AEs', 'timeFrame': 'Up to 77 days'}, {'measure': 'Outcome of all AEs', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of all serious adverse events (SAEs)', 'timeFrame': 'Up to 77 days'}, {'measure': 'Severity of all SAEs', 'timeFrame': 'Up to 77 days'}, {'measure': 'Outcome of all SAEs', 'timeFrame': 'Up to 77 days'}, {'measure': 'Severity of all AEs regardless of seriousness criteria', 'timeFrame': 'Up to 77 days'}, {'measure': 'Investigator causality assessment of all AEs regardless of seriousness criteria', 'timeFrame': 'Up to 77 days'}, {'measure': 'Outcomes of all AEs regardless of seriousness criteria', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in physical examination findings', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval', 'timeFrame': 'Up to 77 days', 'description': 'PR interval: The time from the onset of the P wave to the start of the QRS complex'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QRS interval', 'timeFrame': 'Up to 77 days', 'description': 'QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QT interval', 'timeFrame': 'Up to 77 days', 'description': 'QT interval: Measured from the beginning of the QRS complex to the end of the T wave'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QTcF interval', 'timeFrame': 'Up to 77 days', 'description': "QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)"}, {'measure': 'Incidence of clinically significant changes in continuous cardiac monitoring data', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in ECG parameters: QT interval', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in vital signs: Body temperature', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in vital signs: Blood pressure', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in vital signs: Heart rate', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 77 days'}, {'measure': 'Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 77 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986166', 'Japan'], '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 evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Japanese (both biological parents are ethnically Japanese)\n* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory evaluations\n* Body Mass Index (BMI) of 18.0 to 32.0 kg/m\\^2, inclusive. BMI = weight (kg)/(height \\[m\\])\\^2\n\nExclusion Criteria:\n\n* Significant acute or chronic medical illness judged to be clinically significant by the investigator and/or Sponsor's medical monitor\n* History of heart disease, retinopathy, uveitis, other clinically significant ocular disease, gastrointestinal disease, stroke or transient ischemic attacks (TIA)\n* Inability to tolerate oral medication\n* Women who are of childbearing potential, breastfeeding, or lactating\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04965402', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of BMS-986166 in Healthy Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy Japanese Participants', 'orgStudyIdInfo': {'id': 'IM018-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel 1: Dose 1', 'interventionNames': ['Drug: BMS-986166']}, {'type': 'EXPERIMENTAL', 'label': 'Panel 2: Dose 2', 'interventionNames': ['Drug: BMS-986166']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'BMS-986166', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Panel 1: Dose 1', 'Panel 2: Dose 2']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials Global', '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'}}}}