Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-25 @ 1:38 PM
Study NCT ID:
NCT04008992
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2019-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2019-06-20', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'up to 7 weeks'}, {'measure': 'AEs leading to discontinuation', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of clinically significant changes in vital signs', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of clinically significant changes in ECG (electrocardiogram)', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of clinically significant changes in physical examinations', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Number of clinically significant changes in clinical laboratory tests', 'timeFrame': 'Up to 7 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum observed concentration(Cmax)- Part A SAD', 'timeFrame': 'up to 7 weeks'}, {'measure': 'Time of maximum observed concentration(Tmax)- Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Terminal elimination rate constant (Lz)-Part A SAD', 'timeFrame': 'up to 7 weeks'}, {'measure': 'Half life (T-HALF)- Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)- Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Area under the concentration-time curve from time zero extrapolated to infinite time(AUC(INF)-Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Apparent total body clearance(CL/F)-Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Apparent volume of distribution at terminal phase(Vz/F)- Part A SAD', 'timeFrame': 'Up to 7 weeks'}, {'measure': 'Maximum observed concentration(Cmax)-Part B and Part C MAD', 'timeFrame': 'Up to 7 years', 'description': 'For day 1 , day 13 and day 14'}, {'measure': 'Time of maximum observed concentration(Tmax)-Part B and Part C MAD', 'timeFrame': 'Up tp 7 weeks', 'description': 'For day 1, day 13 and day 14'}, {'measure': 'Area under the concentration-time curve in one dosing interval(AUC(TAU)- Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For day 1 and day 14'}, {'measure': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration(AUC(0-T)-Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For Day 14'}, {'measure': 'Terminal elimination rate constant (Lz)-Part B and Part C MAD', 'timeFrame': 'up to 7 weeks', 'description': 'For day 14'}, {'measure': 'Half life (T-HALF)- Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For day 14'}, {'measure': 'Apparent total body clearance(CL/F)-Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For day 14'}, {'measure': 'Apparent volume of distribution at terminal phase(Vz/F)- Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For day 14'}, {'measure': 'Accumulation Ratio Cmax (AR(Cmax)-Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'For day 14'}, {'measure': 'Accumulation Ratio AUC(TAU) (AR(AUC[TAU])- Part B and Part C MAD', 'timeFrame': 'Up to 7 weeks', 'description': 'for day 14'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, '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/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'A Randomized double blind, placebo controlled study of BMS-986259 to evaluate the safety and effectiveness of the drug amongst different conditions and populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants with a body mass Index (BMI) of 18.0 kg/m\\^2 - 30.0 kg/m\\^2.\n* Males and females not of child bearing potential.\n* Participants in the Japanese Cohorts in Part C must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese.)\n\nExclusion Criteria:\n\n* Any previous dosing in another cohort in the current study or participation in an investigational drug within 2 months prior to (the first) drug administration in the current study.\n* Any Significant Acute or Chronic medical Illness, major surgery in 12 months, or so smoking or used smoking cessation in 3 months.\n* Inability to be venipunctured and/or tolerate venous access. ,abnormalities in hemoglobin or positive screen for hepatitis C, Hepatitis B, Human Immunodeficiency Virus (HIV), including hepatic disease'}, 'identificationModule': {'nctId': 'NCT04008992', 'briefTitle': 'An Ascending Dose Study of BMS-986259 to Study Safety in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.', 'orgStudyIdInfo': {'id': 'CV019-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A SAD - A1 Cohort', 'description': 'Single Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD - A2 Cohort', 'description': 'Single Ascending dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD- A3 Cohort', 'description': 'Single Ascending dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD- A4 Cohort', 'description': 'Single Ascending dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD - A5 Cohort', 'description': 'Single Ascending dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD- A6 Cohort', 'description': 'Single Ascending dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD- B1 Cohort', 'description': 'Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD - B2 Cohort', 'description': 'Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD - B3 Cohort', 'description': 'Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD - B4 Cohort', 'description': 'Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part C JMAD - C1 Cohort', 'description': 'Japanese Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part C JMAD - C2 Cohort', 'description': 'Japanese Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}, {'type': 'EXPERIMENTAL', 'label': 'Part C JMAD - C3 Cohort', 'description': 'Japanese Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986259', 'Other: Placebo', 'Diagnostic Test: P-Aminohippurate', 'Diagnostic Test: Iohexol']}], 'interventions': [{'name': 'BMS-986259', 'type': 'DRUG', 'description': 'Single and Multiple ascending dose from Dose 1 to Dose 5', 'armGroupLabels': ['Part A SAD - A1 Cohort', 'Part A SAD - A2 Cohort', 'Part A SAD - A5 Cohort', 'Part A SAD- A3 Cohort', 'Part A SAD- A4 Cohort', 'Part A SAD- A6 Cohort', 'Part B MAD - B2 Cohort', 'Part B MAD - B3 Cohort', 'Part B MAD - B4 Cohort', 'Part B MAD- B1 Cohort', 'Part C JMAD - C1 Cohort', 'Part C JMAD - C2 Cohort', 'Part C JMAD - C3 Cohort']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo matching BMS-986259', 'armGroupLabels': ['Part A SAD - A1 Cohort', 'Part A SAD - A2 Cohort', 'Part A SAD - A5 Cohort', 'Part A SAD- A3 Cohort', 'Part A SAD- A4 Cohort', 'Part A SAD- A6 Cohort', 'Part B MAD - B2 Cohort', 'Part B MAD - B3 Cohort', 'Part B MAD - B4 Cohort', 'Part B MAD- B1 Cohort', 'Part C JMAD - C1 Cohort', 'Part C JMAD - C2 Cohort', 'Part C JMAD - C3 Cohort']}, {'name': 'P-Aminohippurate', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic Agent', 'armGroupLabels': ['Part A SAD - A1 Cohort', 'Part A SAD - A2 Cohort', 'Part A SAD - A5 Cohort', 'Part A SAD- A3 Cohort', 'Part A SAD- A4 Cohort', 'Part A SAD- A6 Cohort', 'Part B MAD - B2 Cohort', 'Part B MAD - B3 Cohort', 'Part B MAD - B4 Cohort', 'Part B MAD- B1 Cohort', 'Part C JMAD - C1 Cohort', 'Part C JMAD - C2 Cohort', 'Part C JMAD - C3 Cohort']}, {'name': 'Iohexol', 'type': 'DIAGNOSTIC_TEST', 'description': 'Diagnostic Agent', 'armGroupLabels': ['Part A SAD - A1 Cohort', 'Part A SAD - A2 Cohort', 'Part A SAD - A5 Cohort', 'Part A SAD- A3 Cohort', 'Part A SAD- A4 Cohort', 'Part A SAD- A6 Cohort', 'Part B MAD - B2 Cohort', 'Part B MAD - B3 Cohort', 'Part B MAD - B4 Cohort', 'Part B MAD- B1 Cohort', 'Part C JMAD - C1 Cohort', 'Part C JMAD - C2 Cohort', 'Part C JMAD - C3 Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'PRA Health Sciences - Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': 'SE1 1YR', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Richmond Pharmacology', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}