Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2026-01-21 @ 3:06 PM
Study NCT ID:
NCT02985632
Status:
WITHDRAWN
Last Update Posted:
2017-02-06
First Post:
2016-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000729678', 'term': 'BMS-986141'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Business objectives have changed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2017-07-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-05', 'lastUpdatePostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of BMS-986141', 'timeFrame': 'Days 1-7 (healthy) Days 1-10 (heaptic Impairment)'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141', 'timeFrame': 'Days 1-7 (healthy) Days 1-10 (heaptic Impairment)'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141', 'timeFrame': 'Days 1-7 (healthy) Days 1-10 (heaptic Impairment)'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141', 'timeFrame': 'Days 1-7 (healthy) Days 1-10 (heaptic Impairment)'}], 'secondaryOutcomes': [{'measure': 'Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation.', 'timeFrame': 'Days 1-7 (healthy) Days 1-10 (heaptic Impairment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatic Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/pages/home.aspx', 'label': 'BMS Clinical Trial Education Resource'}, {'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'}]}, 'descriptionModule': {'briefSummary': 'An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive.\n* BMI of 20.0 to 38.0 kg/m2 inclusive\n* Participants who a history of normal renal function\n* Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen\n* Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n\nExclusion Criteria:\n\n* Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator.\n* History of recurrent dizziness or fall risk within 4 weeks of study drug administration\n* History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis\n* History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura)\n* Other protocol defined exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT02985632', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Single-dose Pharmacokinetics of BMS-986141 in Participants With Hepatic Impairment Compared to Healthy Participants', 'orgStudyIdInfo': {'id': 'CV006-030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild Hepatic Impairment Subjects', 'description': 'Subjects given an oral dose of BMS-986141.', 'interventionNames': ['Drug: BMS-986141']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Hepatic Impairment Subjects', 'description': 'Subjects given an oral dose of BMS-986141.', 'interventionNames': ['Drug: BMS-986141']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy Subjects', 'description': 'Subjects given an oral dose of BMS-986141.', 'interventionNames': ['Drug: BMS-986141']}], 'interventions': [{'name': 'BMS-986141', 'type': 'DRUG', 'armGroupLabels': ['Healthy Subjects', 'Mild Hepatic Impairment Subjects', 'Moderate Hepatic Impairment Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Pharmacology of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Liver Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}