Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:59 AM
Study NCT ID:
NCT06877702
Status:
RECRUITING
Last Update Posted:
2025-11-17
First Post:
2025-03-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-14', 'studyFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2025-03-10', 'lastUpdatePostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately Day 43'}, {'measure': 'Part 1: Number of Participants With Serious AEs (SAEs)', 'timeFrame': 'Up to approximately Day 43'}, {'measure': 'Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Time of Maximum Plasma Observed Concentration (Tmax) of BMS-986460', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC [0-T]) of BMS-986460', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) of BMS-986460', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: Relative Bioavailability (rBA) of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on Geometric Mean Ratio (GMR) of Cmax', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(0-T)', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 1: rBA of Alternate Formulations of BMS-986460 as Compared to Reference Formulation Based on GMR of AUC(INF)', 'timeFrame': 'Up to approximately Day 21'}, {'measure': 'Part 2: Number of Participants With AEs', 'timeFrame': 'Up to approximately Day 29'}, {'measure': 'Part 2: Number of Participants With SAEs', 'timeFrame': 'Up to approximately Day 29'}, {'measure': 'Part 2: Number of Participants With Clinically Significant PE Findings', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: Number of Participants With Clinically Significant Vital Sign Abnormalities', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: Number of Participants With Clinically Significant 12-lead ECG Findings', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: Cmax of BMS-986460', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: Tmax of BMS-986460', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: AUC [0-T] of BMS-986460', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: AUC(INF) of BMS-986460', 'timeFrame': 'Up to approximately Day 7'}], 'secondaryOutcomes': [{'measure': 'Part 2: Pharmacokinetic (PK) Linearity of BMS-986460 Based on Cmax', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: PK Linearity of BMS-986460 Based on AUC(0-T)', 'timeFrame': 'Up to approximately Day 7'}, {'measure': 'Part 2: PK Linearity of BMS-986460 Based on AUC(INF)', 'timeFrame': 'Up to approximately Day 7'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BMS-986460, bioavailability, healthy adult male, crossover, SAD'], '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/us/en/clinical-trials/NCT06877702.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator.\n* Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive.\n* Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception.\n\nExclusion Criteria:\n\n* Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded.\n* Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.\n* Participants with history of anaphylactic reactions are excluded.\n* Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded.\n* Participants with history of Gilbert's syndrome are excluded.\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06877702', 'briefTitle': 'A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)', 'orgStudyIdInfo': {'id': 'CA125-1018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Sequence 1', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Sequence 2', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Sequence 3', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment A', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Treatment B', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Optional Treatment C', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Optional Treatment D', 'interventionNames': ['Drug: BMS-986460']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Optional Treatment E', 'interventionNames': ['Drug: BMS-986460']}], 'interventions': [{'name': 'BMS-986460', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Part 1: Sequence 1', 'Part 1: Sequence 2', 'Part 1: Sequence 3', 'Part 2: Optional Treatment C', 'Part 2: Optional Treatment D', 'Part 2: Optional Treatment E', 'Part 2: Treatment A', 'Part 2: Treatment B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrick Yao, Site 0001', 'role': 'CONTACT', 'phone': '913-410-2674'}], 'facility': 'ICON Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], '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': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}