Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-01 @ 11:05 PM
Study NCT ID:
NCT04956627
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2021-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706608', 'term': 'BMS-986166'}, {'id': 'D017964', 'term': 'Itraconazole'}, {'id': 'D010672', 'term': 'Phenytoin'}, {'id': 'D015248', 'term': 'Gemfibrozil'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006827', 'term': 'Hydantoins'}, {'id': 'D048289', 'term': 'Imidazolidines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D058607', 'term': 'Fibric Acids'}, {'id': 'D058610', 'term': 'Isobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010421', 'term': 'Pentanoic Acids'}, {'id': 'D014631', 'term': 'Valerates'}, {'id': 'D010647', 'term': 'Phenyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-11', 'studyFirstSubmitDate': '2021-07-01', 'studyFirstSubmitQcDate': '2021-07-01', 'lastUpdatePostDateStruct': {'date': '2022-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'Cmax of BMT-121795', 'timeFrame': 'Up to Day 22'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'Tmax of BMT-121795', 'timeFrame': 'Up to Day 22'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'AUC(0-T) of BMT-121795', 'timeFrame': 'Up to Day 22'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'AUC(INF) of BMT-121795', 'timeFrame': 'Up to Day 22'}, {'measure': 'Terminal plasma half-life (T-HALF) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'T-HALF of BMT-121795', 'timeFrame': 'Up to Day 22'}, {'measure': 'Apparent total body clearance (CL/F) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'Apparent volume of distribution (Vz/F) of BMS-986166', 'timeFrame': 'Up to Day 22'}, {'measure': 'Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)', 'timeFrame': 'Up to Day 22'}, {'measure': 'Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))', 'timeFrame': 'Up to Day 22'}, {'measure': 'Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))', 'timeFrame': 'Up to Day 22'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in ECG parameters: PR interval', 'timeFrame': 'Up to Day 55', 'description': 'PR interval is the time from the onset of the P wave to the start of the QRS complex'}, {'measure': 'Number of participants with clinically significant changes in ECG parameters: QRS', 'timeFrame': 'Up to Day 55', 'description': 'QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization'}, {'measure': 'Number of participants with clinically significant changes in ECG parameters: QT interval', 'timeFrame': 'Up to Day 55', 'description': 'The QT interval is the time from the start of the Q wave to the end of the T wave'}, {'measure': 'Number of participants with clinically significant changes in ECG parameters: QTcF', 'timeFrame': 'Up to Day 55', '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': 'Number of participants with clinically significant changes in laboratory values: Hematology tests', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in laboratory values: Chemistry tests', 'timeFrame': 'Up to Day 55'}, {'measure': 'Number of participants with clinically significant changes in laboratory values: Urinalysis', 'timeFrame': 'Up to Day 55'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Participants', 'BMS-986166'], '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.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 effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight of at least 55 kg.\n* Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height \\[m\\])².\n* Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.\n* History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.\n* History of stroke or transient ischemic attacks.\n* History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04956627', 'briefTitle': 'A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM018-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986166', 'interventionNames': ['Drug: BMS-986166']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986166 + Itraconazole', 'interventionNames': ['Drug: BMS-986166', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986166 + Phenytoin', 'interventionNames': ['Drug: BMS-986166', 'Drug: Extended Phenytoin Sodium']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-986166 + Gemfibrozil', 'interventionNames': ['Drug: BMS-986166', 'Drug: Gemfibrozil']}], 'interventions': [{'name': 'BMS-986166', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986166', 'BMS-986166 + Gemfibrozil', 'BMS-986166 + Itraconazole', 'BMS-986166 + Phenytoin']}, {'name': 'Itraconazole', 'type': 'DRUG', 'otherNames': ['Sporanox'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986166 + Itraconazole']}, {'name': 'Extended Phenytoin Sodium', 'type': 'DRUG', 'otherNames': ['Dilantin'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986166 + Phenytoin']}, {'name': 'Gemfibrozil', 'type': 'DRUG', 'otherNames': ['Lopid'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-986166 + Gemfibrozil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Hassman Research Institute', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}