Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 4:20 AM
Study NCT ID:
NCT05806359
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2023-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2023-03-29', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Day 1 up to Day 28'}, {'measure': 'Number of Participants with Vital Sign Abnormalities', 'timeFrame': 'Day 1 up to Day 7'}, {'measure': 'Number of Participants with Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Day 1 up to Day 7'}, {'measure': 'Number of Participants with Physical Examination Abnormalities', 'timeFrame': 'Day 1 up to Day 7'}, {'measure': 'Number of Participants with Clinical Laboratory Abnormalities', 'timeFrame': 'Day 1 up to Day 7'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Predose and at multiple timepoints (Day 1 up to Day 6) after dosing'}, {'measure': 'Time of Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Predose and at multiple timepoints (Day 1 up to Day 6) after dosing'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(0-inf)]', 'timeFrame': 'Predose and at multiple timepoints (Day 1 up to Day 6) after dosing'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy', 'Danicamtiv', 'Japanese', 'Caucasian'], '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/content/studyconnect/us/en/clinical-trials/NCT05806359.html', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, and single-dose pharmacokinetics of danicamtiv in healthy Japanese and Caucasian participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 18 and 30 kilograms/meter squared inclusive, at the screening visit.\n* Japanese participants must be of Japanese descent (both biological parents are ethnically Japanese).\n* Caucasian participants must be of European or Latin American Caucasian descent.\n* A female participant is eligible to participate if she is a woman of nonchildbearing potential as defined in the protocol.\n* Males who are sexually active with woman of childbearing potential must agree to follow protocol-defined instructions for method(s) of contraception.\n\nExclusion Criteria:\n\n* Any acute or chronic medical illness.\n* Active infection, including with coronavirus disease-19, diagnosed clinically by the investigator.\n* History of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or sponsor clinical trial physician, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.\n\nNote: Other protocol-defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT05806359', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Drug Levels of Danicamtiv in Healthy Japanese and Caucasian Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Danicamtiv in Healthy Japanese and Caucasian Participants', 'orgStudyIdInfo': {'id': 'CV028-1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort - Dose 1', 'interventionNames': ['Drug: Danicamtiv', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort - Dose 2', 'interventionNames': ['Drug: Danicamtiv', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Japanese Cohort - Dose 3', 'interventionNames': ['Drug: Danicamtiv', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Caucasian Cohort - Dose 3', 'interventionNames': ['Drug: Danicamtiv', 'Drug: Placebo']}], 'interventions': [{'name': 'Danicamtiv', 'type': 'DRUG', 'otherNames': ['BMS-986434', 'MYK-491'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Caucasian Cohort - Dose 3', 'Japanese Cohort - Dose 1', 'Japanese Cohort - Dose 2', 'Japanese Cohort - Dose 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Caucasian Cohort - Dose 3', 'Japanese Cohort - Dose 1', 'Japanese Cohort - Dose 2', 'Japanese Cohort - Dose 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}