Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-30 @ 9:31 PM
Study NCT ID:
NCT05805904
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2023-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese 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': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-15', 'studyFirstSubmitDate': '2023-03-28', 'studyFirstSubmitQcDate': '2023-03-28', 'lastUpdatePostDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax)', 'timeFrame': 'Up to Day 19'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to Day 19'}, {'measure': 'Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Up to Day 19'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 26'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 19'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to Day 19'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to Day 19'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to Day 19'}, {'measure': 'Cmax', 'timeFrame': 'Up to Day 19'}, {'measure': 'Tmax', 'timeFrame': 'Up to Day 19'}, {'measure': 'AUC(0-T)', 'timeFrame': 'Up to Day 19'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants must be Chinese (both biological parents are ethnically Chinese).\n* Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.\n* Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height \\[m\\])2.\n* Body weight ≥ 50 kg\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome\n* Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome)\n* Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable)\n* Women who are of childbearing potential\n* Women who are breastfeeding\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate \\< 90 mL/min/1.732 m\\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine\n\nOther protocol-defined inclusion/exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05805904', 'briefTitle': 'A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants', 'orgStudyIdInfo': {'id': 'IM027-067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'interventionNames': ['Drug: BMS-986278', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'interventionNames': ['Drug: BMS-986278', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-986278', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}