Ignite Creation Date:
2025-12-26 @ 10:37 AM
Ignite Modification Date:
2026-03-03 @ 10:22 AM
Study NCT ID:
NCT03374228
Status:
COMPLETED
Last Update Posted:
2018-06-28
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Bioavailability of BMS-986205
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630574', 'term': 'linrodostat'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute oral bioavailability (F)', 'timeFrame': 'Up to 15 days', 'description': 'Measured by plasma concentration'}], 'secondaryOutcomes': [{'measure': 'Occurrence of adverse events (AEs)', 'timeFrame': 'Up to 15 days', 'description': 'Safety and tolerability as measured by incidence of AEs'}, {'measure': 'Occurrence of serious adverse events (SAEs)', 'timeFrame': 'Up to 15 days', 'description': 'Safety and tolerability as measured by incidence of SAEs'}, {'measure': 'Occurrence of adverse events (AEs) leading to discontinuation', 'timeFrame': 'Up to 15 days', 'description': 'Safety and tolerability as measured by incidence of AEs leading to discontinuation'}, {'measure': 'Number of participants with vital sign measurement abnormalities', 'timeFrame': 'Up to 15 days'}, {'measure': 'Number of participants with electrocardiogram abnormalities', 'timeFrame': 'Up to 15 days'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 15 days'}, {'measure': 'Number of participants with clinical laboratory test abnormalities', 'timeFrame': 'Up to 15 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, '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': 'Assess the absolute bioavailability of a tablet formulation of BMS-986205 following simultaneous oral administration of BMS-986205 and intravenous infusion of \\[13C\\]BMS-986205 solution for intravenous administration in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive\n* Must have normal renal function demonstrated by an estimated glomerular filtration rate, calculated by Chronic Kidney Disease Epidemiology Collaboration formula\n* Women must not be of childbearing potential (cannot become pregnant)\n\nExclusion Criteria:\n\n* Women who are of childbearing potential or breastfeeding\n* Any significant acute or chronic medical illness\n* Active tuberculosis (TB) requiring treatment or documented latent TB at screening\n\nOther protocol defined inclusion / exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03374228', 'briefTitle': 'A Study to Evaluate the Bioavailability of BMS-986205', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation', 'orgStudyIdInfo': {'id': 'CA017-060'}, 'secondaryIdInfos': [{'id': '2017-003100-51', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-986205', 'description': 'Single oral dose of BMS-986205 tablet on the morning of Day 1 followed by a 15-minute infusion of \\[13C\\]BMS-986205 solution for intravenous administration starting 01:45 hours after the oral dose administration', 'interventionNames': ['Drug: BMS-986205']}], 'interventions': [{'name': 'BMS-986205', 'type': 'DRUG', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['BMS-986205']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Nottingham', 'state': 'Ruddington Fields', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}