Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
Study NCT ID:
NCT04444050
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2020-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-22', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 13 months'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 46 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 46 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 46 days'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Up to 17 days'}, {'measure': 'Time to reach Cmax in plasma (Tmax)', 'timeFrame': 'Up to 17 days'}, {'measure': 'Area under the plasma concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed [AUC(0-T)]', 'timeFrame': 'Up to 17 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy participants'], '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'}, {'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 single and multiple oral doses of BMS-986331 versus placebo in healthy participants and healthy Japanese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant deviations in medical history, physical examination, ECGs, vital signs, and clinical laboratory determinations\n* A body mass index of 18 - 32 kg/m2, inclusive\n* Women and men must agree to follow specific methods of contraception, if applicable\n\nFor J-MAD Part 3\n\n* Must be Japanese (both biological parents are ethnically Japanese)\n\nExclusion Criteria:\n\n* Women who are of childbearing potential\n* Women who are pregnant or breastfeeding\n* Any significant acute or chronic medical illness\n* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug\n* Any surgery within 12 weeks of study drug administration\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04444050', 'briefTitle': 'Study to Evaluate the Safety, Tolerability, Drug Levels and Drug Effects of BMS-986331 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS-986331 in Healthy Participants', 'orgStudyIdInfo': {'id': 'CV023-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Single Ascending Dose (SAD): Panel 1', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Panel 2', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Panel 3', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Panel 4', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Panel 5', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Panel 6', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 SAD: Optional Split-dose Panel', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Multiple Ascending Dose (MAD): Panel 1', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 MAD: Panel 2', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 MAD: Panel 3', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 MAD: Panel 4', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 MAD: Optional (to be determined) Panel', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 MAD in Japanese Participants (J-MAD): Panel 1', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 J-MAD: Panel 2', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 J-MAD: Panel 3', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 J-MAD: Optional (to be determined) Panel', 'interventionNames': ['Drug: BMS-986331', 'Other: Placebo, Matching BMS-986331']}], 'interventions': [{'name': 'BMS-986331', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1 SAD: Optional Split-dose Panel', 'Part 1 SAD: Panel 2', 'Part 1 SAD: Panel 3', 'Part 1 SAD: Panel 4', 'Part 1 SAD: Panel 5', 'Part 1 SAD: Panel 6', 'Part 1 Single Ascending Dose (SAD): Panel 1', 'Part 2 MAD: Optional (to be determined) Panel', 'Part 2 MAD: Panel 2', 'Part 2 MAD: Panel 3', 'Part 2 MAD: Panel 4', 'Part 2 Multiple Ascending Dose (MAD): Panel 1', 'Part 3 J-MAD: Optional (to be determined) Panel', 'Part 3 J-MAD: Panel 2', 'Part 3 J-MAD: Panel 3', 'Part 3 MAD in Japanese Participants (J-MAD): Panel 1']}, {'name': 'Placebo, Matching BMS-986331', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part 1 SAD: Optional Split-dose Panel', 'Part 1 SAD: Panel 2', 'Part 1 SAD: Panel 3', 'Part 1 SAD: Panel 4', 'Part 1 SAD: Panel 5', 'Part 1 SAD: Panel 6', 'Part 1 Single Ascending Dose (SAD): Panel 1', 'Part 2 MAD: Optional (to be determined) Panel', 'Part 2 MAD: Panel 2', 'Part 2 MAD: Panel 3', 'Part 2 MAD: Panel 4', 'Part 2 Multiple Ascending Dose (MAD): Panel 1', 'Part 3 J-MAD: Optional (to be determined) Panel', 'Part 3 J-MAD: Panel 2', 'Part 3 J-MAD: Panel 3', 'Part 3 MAD in Japanese Participants (J-MAD): Panel 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON (LPRA) - Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}