Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-02-25 @ 5:50 PM
Study NCT ID:
NCT03224260
Status:
COMPLETED
Last Update Posted:
2018-06-01
First Post:
2017-07-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720754', 'term': 'milvexian'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2017-07-18', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Death', 'timeFrame': '30 days after last dose', 'description': 'Measured by investigator assessment'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': '30 days after last dose', 'description': 'Measured by investigator assessment'}, {'measure': 'Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy', 'timeFrame': '17 days', 'description': 'Measured by investigator assessment'}, {'measure': 'Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding', 'timeFrame': '17 days', 'description': 'Measured by investigator assessment'}, {'measure': 'Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature)', 'timeFrame': '17 days', 'description': 'Measured by investigator assessment'}, {'measure': 'Change from baseline in electrocardiogram findings (ECGs)', 'timeFrame': '17 days', 'description': 'Measured by investigator assessment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx', 'label': 'Investigator Inquiry Form'}, {'url': 'http://www.fda.gov/safety/recalls/', 'label': 'FDA Safety Alerts and Recalls'}, {'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 educational resource'}]}, 'descriptionModule': {'briefSummary': 'Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be first-generation Japanese (born in Japan and not living outside of Japan for \\> 10 years; both parents must be ethnically Japanese)\n* Body Mass Index 18.0 to 25.0 kg/m2, inclusive\n* Women must not be of nonchildbearing potential (cannot become pregnant)\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)\n* History or evidence of abnormal bleeding or coagulation disorder\n\nOther protocol defined inclusion and exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT03224260', 'briefTitle': 'To Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Healthy Japanese Participants', 'orgStudyIdInfo': {'id': 'CV010-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Receive 50 mg BMS-986177 once daily or placebo', 'interventionNames': ['Drug: BMS-986177', 'Other: Matched Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Receive 200 mg BMS-986177 once daily or placebo', 'interventionNames': ['Drug: BMS-986177', 'Other: Matched Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Receive 500 mg BMS-986177 once daily or placebo', 'interventionNames': ['Drug: BMS-986177', 'Other: Matched Placebo']}], 'interventions': [{'name': 'BMS-986177', 'type': 'DRUG', 'description': 'Oral Suspension', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C']}, {'name': 'Matched Placebo', 'type': 'OTHER', 'description': 'Oral Suspension', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'West Coast Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}