Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2025-12-28 @ 6:36 AM
Study NCT ID:
NCT05963932
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2023-07-20', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 15 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])', 'timeFrame': 'Up to 15 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])', 'timeFrame': 'Up to 15 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 29 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 29 days'}, {'measure': 'Time to attain maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 15 days'}, {'measure': 'Terminal half-life (T-Half)', 'timeFrame': 'Up to 15 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))', 'timeFrame': 'Up to 15 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986419', 'Healthy male of non-child bearing potential', 'Healthy women of non-child bearing potential'], '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 assess the impact of the BMS-986419 new immediate release (IR) tablet formulation compared to the current enteric (DR) capsule formulation, and to assess the effect of food on the drug levels of the IR tablet formulation in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy male and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations.\n* Body mass index (BMI) of 18.0 to 32.0 kilograms per meter squared (kg/m\\^2), inclusive, and body weight ≥ 50 kg.\n* A female participant is eligible to participate if she is a woman not of childbearing potential (WNOCBP)\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness (eg, history of intracranial or intraspinal hemorrhage, CNS lesions, recent bacterial or fungal meningitis, etcetera) as determined by the investigator.\n* Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could affect the absorption, distribution, metabolism, and excretion of study intervention (for example, bariatric procedure).\n* History of Gilbert's syndrome.\n* Women who are of childbearing potential and women who are breastfeeding."}, 'identificationModule': {'nctId': 'NCT05963932', 'briefTitle': 'A Study to Assess the Bioavailability and Effect of Food of BMS-986419 Immediate-release Tablet Formulation in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, Parallel-group, Single Dose Study to Assess the Relative Bioavailability of a New BMS-986419 Immediate-release Tablet Formulation Compared to a Reference Enteric Capsule (Delayed-release) Formulation, and to Assess the Effect of Food on the Pharmacokinetics of Immediate-release Tablet Formulation in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'CN007-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: BMS-986419 DR Capsule - Fasted', 'interventionNames': ['Drug: BMS-986419 DR Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: BMS-986419 IR Tablet - Fasted', 'interventionNames': ['Drug: BMS-986419 IR Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: BMS-986419 IR Tablet - Fed', 'interventionNames': ['Drug: BMS-986419 IR Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D: BMS-986419 Crushed IR Tablet - Fed', 'interventionNames': ['Drug: BMS-986419 IR Tablet']}], 'interventions': [{'name': 'BMS-986419 DR Capsule', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Treatment A: BMS-986419 DR Capsule - Fasted']}, {'name': 'BMS-986419 IR Tablet', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Treatment B: BMS-986419 IR Tablet - Fasted', 'Treatment C: BMS-986419 IR Tablet - Fed', 'Treatment D: BMS-986419 Crushed IR Tablet - Fed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', '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-andpartners/ clinical-trials-andresearch/disclosure-commitment.html"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}