Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05866627
Status:
RECRUITING
Last Update Posted:
2025-01-22
First Post:
2023-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-20', 'studyFirstSubmitDate': '2023-05-10', 'studyFirstSubmitQcDate': '2023-05-10', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 20 Days'}, {'measure': 'Time to attain maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to 20 Days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])', 'timeFrame': 'Up to 20 Days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events (AEs)', 'timeFrame': 'Up to 52 Days'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to 52 Days'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 52 Days'}, {'measure': 'Number of participants with electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to 52 Days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986256', 'Famotidine', 'Gastric pH'], '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.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\\^2) and 32.0 kg/m\\^2, inclusive, at screening.\n* A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.\n* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m\\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness.\n* Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.\n* GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT05866627', 'briefTitle': 'A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM026-1023'}, 'secondaryIdInfos': [{'id': '1007296', 'type': 'OTHER', 'domain': 'IRAS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Afimetoran, followed by famotidine + afimetoran', 'interventionNames': ['Drug: Famotidine', 'Drug: Afimetoran']}, {'type': 'EXPERIMENTAL', 'label': 'Famotidine + afimetoran, followed by afimetoran', 'interventionNames': ['Drug: Famotidine', 'Drug: Afimetoran']}, {'type': 'EXPERIMENTAL', 'label': 'Afimetoran', 'interventionNames': ['Drug: Afimetoran']}, {'type': 'EXPERIMENTAL', 'label': 'Famotidine, followed by afimetoran', 'interventionNames': ['Drug: Famotidine', 'Drug: Afimetoran']}], 'interventions': [{'name': 'Famotidine', 'type': 'DRUG', 'otherNames': ['Pepcid'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Afimetoran, followed by famotidine + afimetoran', 'Famotidine + afimetoran, followed by afimetoran', 'Famotidine, followed by afimetoran']}, {'name': 'Afimetoran', 'type': 'DRUG', 'otherNames': ['BMS-986256'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Afimetoran', 'Afimetoran, followed by famotidine + afimetoran', 'Famotidine + afimetoran, followed by afimetoran', 'Famotidine, followed by afimetoran']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'state': 'Nottinghamshire', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Philip Evans, Site 0001', 'role': 'CONTACT', 'phone': '4401159749000'}], 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain the NCT# and Site #.', 'role': 'CONTACT'}], '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. Additional information regarding Bristol Myers 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'}}}}