Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 7:12 AM
Study NCT ID:
NCT04949269
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2021-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-24', 'studyFirstSubmitDate': '2021-06-30', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2022-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of deucravacitinib', 'timeFrame': 'Up to 7 days'}, {'measure': 'Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib', 'timeFrame': 'Up to 7 days'}, {'measure': 'Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib', 'timeFrame': 'Up to 7 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of non-serious Adverse Events (AEs)', 'timeFrame': 'Up to 18 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': "Up to 30 days post discontinuation of dosing or participant's participation in the study"}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Hematology tests', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Chemistry tests', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 11 days'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval', 'timeFrame': 'Up to 11 days', 'description': 'PR interval is the time from the onset of the P wave to the start of the QRS complex'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QRS', 'timeFrame': 'Up to 11 days', 'description': 'QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QT interval', 'timeFrame': 'Up to 11 days', 'description': 'The QT interval is the time from the start of the Q wave to the end of the T wave'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QTcF', 'timeFrame': 'Up to 11 days', 'description': 'QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Participants', 'Deucravacitinib', 'BMS-986165'], '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.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the drug levels of deucravacitinib after oral administration in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit: www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations.\n* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb).\n* Willing and able to consume 4 units of alcohol (Part C only). Only participants with low to moderate alcohol consumption will be enrolled in Part C of this study (ie, consumption of between 1 and 21 units per week for males and between 1 and 14 units per week in females).\n\nExclusion Criteria:\n\n* Current or recent (within 3 months or 90 days of study drug administration) clinically significant gastrointestinal disease that, in the opinion of the investigator or medical monitor, could impact upon the absorption of study drug.\n* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.\n* Clinically significant history or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months or 90 days prior to screening.\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04949269', 'briefTitle': 'A Study to Evaluate the Drug Levels of Deucravacitinib From Tablets After Oral Administration in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of Deucravacitinib (BMS-986165) Administered as Various Solid Tablet Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM011-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'interventionNames': ['Drug: Deucravacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'Part C', 'interventionNames': ['Drug: Deucravacitinib', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Part D', 'interventionNames': ['Drug: Deucravacitinib']}], 'interventions': [{'name': 'Deucravacitinib', 'type': 'DRUG', 'otherNames': ['BMS-986165'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A', 'Part B', 'Part C', 'Part D']}, {'name': 'Famotidine', 'type': 'DRUG', 'otherNames': ['Pepcid'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Quotient Sciences Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Development, LP', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}