Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT05546151
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2022-09-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent
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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2022-09-15', 'studyFirstSubmitQcDate': '2022-09-15', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with serious adverse events (SAEs)', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with adverse events (AEs) leading to discontinuation', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of deaths', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with AEs', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 7 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Day 1 and Day 14'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Day 1 and Day 14'}, {'measure': 'Area under the concentration-time curve within a dosing interval (AUC[TAU])', 'timeFrame': 'Day 1 and Day 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986322', 'Japanese descent'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'http://www.BMSStudyConnect.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be of Japanese descent (both biological parents are ethnically Japanese).\n* In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.\n* Women should be of non-childbearing potential.\n\nExclusion Criteria:\n\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 major surgery within 90 days of study drug administration.\n\nOther protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05546151', 'briefTitle': 'A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent', 'orgStudyIdInfo': {'id': 'IM032-042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort J1', 'interventionNames': ['Drug: BMS-986322', 'Other: Placebo for BMS-986322']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort J2', 'interventionNames': ['Drug: BMS-986322', 'Other: Placebo for BMS-986322']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort J3', 'interventionNames': ['Drug: BMS-986322', 'Other: Placebo for BMS-986322']}], 'interventions': [{'name': 'BMS-986322', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort J1', 'Cohort J2', 'Cohort J3']}, {'name': 'Placebo for BMS-986322', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Cohort J1', 'Cohort J2', 'Cohort J3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials Llc', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}