Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-01-01 @ 4:08 AM
Study NCT ID:
NCT04055506
Status:
COMPLETED
Last Update Posted:
2020-06-18
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628674', 'term': 'deucravacitinib'}, {'id': 'D019438', 'term': 'Ritonavir'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-09-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986165', 'timeFrame': 'Day 1'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165', 'timeFrame': 'Day 1'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165', 'timeFrame': 'Day 1'}, {'measure': 'Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir', 'timeFrame': 'Day 15'}, {'measure': 'Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir', 'timeFrame': 'Day 15'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir', 'timeFrame': 'Day 15'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'vital signs of blood pressure', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'Vital signs of body temperature', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'Vital signs of respiratory rate', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'Number of Clinically significant changes in lab assessment of blood serum', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'Number of Clinically significant changes in the lab assessment of blood', 'timeFrame': 'initial dose up to day 29'}, {'measure': 'Number of Clinically significant changes in the lab assessment of urine', 'timeFrame': 'initial dose up to day 29'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The Study of Cytochrome P450 1A2 Induction by Ritonavir on the drug effects of BMS-986165 in Healthy Participants'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \\> 80 mL/min/1.732 m2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic onadotropin) within 24 hours prior to the start of study treatment.\n* Body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive, and body weight ≥ 50 kg, at screening.\n\nExclusion Criteria:\n\n* Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population.\n* Prisoners or participants who are involuntarily incarcerated\n* Any significant acute or chronic 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'}, 'identificationModule': {'nctId': 'NCT04055506', 'briefTitle': 'A Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on BMS-986165 Drug Levels and Effects in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Induction by Ritonavir on the Pharmacokinetics of BMS-986165 in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM011-087'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination Therapy', 'interventionNames': ['Drug: BMS-986165', 'Drug: Ritonavir']}], 'interventions': [{'name': 'BMS-986165', 'type': 'DRUG', 'description': 'Dose 1', 'armGroupLabels': ['Combination Therapy']}, {'name': 'Ritonavir', 'type': 'DRUG', 'description': '100 mg', 'armGroupLabels': ['Combination Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences - Salt Lake', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}