Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-28 @ 4:15 AM
Study NCT ID:
NCT04536961
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2020-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D015738', 'term': 'Famotidine'}, {'id': 'D000431', 'term': 'Ethanol'}], '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'}, {'id': 'D000438', 'term': 'Alcohols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2020-08-28', 'studyFirstSubmitQcDate': '2020-08-28', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986165', 'timeFrame': 'Day 1 and Day 7'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-986165', 'timeFrame': 'Day 1 and Day 7'}, {'measure': 'Area under the plasma concentration-time curve from time zero to t (AUC (0-t)) of BMS-986165', 'timeFrame': 'Day 1 and Day 7', 'description': 'Part A, B, C'}], 'secondaryOutcomes': [{'measure': 'Incidence of Nonserious Adverse Events (AEs)', 'timeFrame': 'Up to approximately 60 days (for Parts A & C), approximately 69 days (for Part B)'}, {'measure': 'Incidence of Serious Adverse Events (AEs)', 'timeFrame': 'Up to approximately 83 days (for Parts A & C), approximately 92 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)', '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.'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)', '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 electrocardiogram (ECG) parameters: QT interval', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)', '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 electrocardiogram (ECG) parameters: PR interval', 'timeFrame': 'Up to approximately 53 days (for Parts A & C), approximately 62 days (for Part B)', 'description': 'PR interval is the time from the onset of the P wave to the start of the QRS complex'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], '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 evaluate the drug levels of BMS-986165 in when taken by mouth as various solid tablet prototypes, by 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* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (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). BMI = weight (kg)/(height \\[m\\])2 at screening.\n* Willing and able to consume 4 units of alcohol (Part B only)\n* A negative polymerase chain reaction (PCR) test for coronavirus disease 2019 (COVID-19) at screening and admission\n* Males and females must agree to follow specific methods of contraception, if applicable\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': 'NCT04536961', 'briefTitle': 'A Study to Evaluate the Drug Levels of BMS-986165 When Taken as Various Solid Tablet Prototypes by Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Open-label, Crossover Study to Evaluate the Pharmacokinetics of BMS-986165 Administered as Various Prototypic Solid Tablet Formulations in Healthy Subjects', 'orgStudyIdInfo': {'id': 'IM011-136'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: Reference Treatment', 'interventionNames': ['Drug: Reference Treatment- BMS-986165-01']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Prototype', 'interventionNames': ['Drug: Prototype BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Reference Treatment', 'interventionNames': ['Drug: Reference Treatment- BMS-986165-01']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: Prototype', 'interventionNames': ['Drug: Prototype BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Treatment 1', 'interventionNames': ['Drug: Prototype BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Treatment 2', 'interventionNames': ['Drug: Prototype BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Treatment 3', 'interventionNames': ['Drug: Prototype BMS-986165']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Treatment 4', 'interventionNames': ['Drug: Prototype BMS-986165', 'Drug: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: Treatment 5', 'interventionNames': ['Drug: Prototype BMS-986165', 'Other: Alcohol']}], 'interventions': [{'name': 'Reference Treatment- BMS-986165-01', 'type': 'DRUG', 'otherNames': ['Deucravacitinib'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: Reference Treatment', 'Part C Reference Treatment']}, {'name': 'Prototype BMS-986165', 'type': 'DRUG', 'otherNames': ['Deucravacitinib'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A Prototype', 'Part B: Treatment 1', 'Part B: Treatment 2', 'Part B: Treatment 3', 'Part B: Treatment 4', 'Part B: Treatment 5', 'Part C: Prototype']}, {'name': 'Famotidine', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part B: Treatment 4']}, {'name': 'Alcohol', 'type': 'OTHER', 'description': 'Specified quantity on specified days', 'armGroupLabels': ['Part B: Treatment 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences Miami', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}