Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-01-02 @ 1:06 PM
Study NCT ID:
NCT06566768
Status:
COMPLETED
Last Update Posted:
2025-07-02
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-30', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-21', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to approximately 5 days'}, {'measure': 'Concentration at 24 hours post dose (C24)', 'timeFrame': 'Up to approximately 5 days'}, {'measure': 'Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to approximately 5 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of serious adverse events (SAEs)', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of AEs leading to discontinuation', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of participants with vital sign abnormalities', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of participants with physical examinations abnormalities', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Incidence of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to approximately 1 month'}, {'measure': 'Time of maximum observed concentration (Tmax)', 'timeFrame': 'Up to approximately 5 days'}, {'measure': 'Apparent terminal plasma half-life (T-HALF)', 'timeFrame': 'Up to approximately 5 days'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to approximately 5 days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deucravacitinib', 'BMS-986165', 'Healthy volunteers', 'Single-dose'], '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.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males and healthy females according to the assessment of the Investigator.\n* Body mass index of 18.0 kg/m\\^2 through 32.0 kg/m\\^2, inclusive, and body weight ≥ 50 kg.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness.\n* Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion.\n* History of any significant drug allergy.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06566768', 'briefTitle': 'Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Oral Gastro-retentive Tablet Formulation Prototypes in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM011-1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Deucravacitinib', 'interventionNames': ['Drug: Deucravacitinib']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['BMS-986165'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: Deucravacitinib', 'Part B: Deucravacitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'country': 'United Kingdom', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], '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.\n\nAdditional information regarding Bristol Myer 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'}}}}