Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-02-03 @ 3:47 AM
Study NCT ID:
NCT03634995
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2018-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-11', 'studyFirstSubmitDate': '2018-08-15', 'studyFirstSubmitQcDate': '2018-08-15', 'lastUpdatePostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Serious Adverse Events (SAE)', 'timeFrame': 'Up to 46 days'}, {'measure': 'Number of deaths', 'timeFrame': 'Up to 46 days'}, {'measure': 'Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory assessments', 'timeFrame': 'Up to 44 days'}, {'measure': 'Number of Adverse Events (AEs) leading to early discontinuation', 'timeFrame': 'Up to 44 days'}, {'measure': 'Maximum concentration (Cmax)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Time of maximum concentration (Tmax)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)]', 'timeFrame': 'Up to 44 days'}], 'secondaryOutcomes': [{'measure': 'Terminal elimination rate constant (kel)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Terminal elimination half-life (T-half)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Apparent oral clearance (CL/F)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Metabolite ratio for AUC(INF) [MR(AUC[INF])]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Metabolite ratio of Cmax [MR(Cmax)]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Apparent volume of distribution at terminal phase (Vz/F)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Plasma concentration immediately prior to dosing (Ctrough)', 'timeFrame': 'Up to 44 days'}, {'measure': 'Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Accumulation ratio of Ctrough [AR(Ctrough)]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Accumulation ratio of AUC(TAU) [AR(AUC[TAU])]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Accumulation ratio of Cmax [AR(Cmax)]', 'timeFrame': 'Up to 44 days'}, {'measure': 'Metabolite ratio for AUC(TAU) [MR(AUC[TAU])]', 'timeFrame': 'Up to 44 days'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, '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': 'The purpose of this study is to evaluate the effects of the experimental medication BMS-986256 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Weight ≥ 50 kg and body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive at screening\n* Participants must not be current users (within 6 months before screening) of tobacco or tobacco- or nicotine-containing products; they must also be willing to refrain from using any of these products during their participation in the study\n* A negative QuantiFERON®-TB Gold test result at screening or documentation of a negative result within 3 months before screening\n\nExclusion Criteria:\n\n* Previous participation in the current study or previous exposure within 6 weeks before study drug administration for non-biologics and 12 weeks before study drug administration for biologics\n* Inability to tolerate oral medication\n* Inability to tolerate venipuncture, or inadequate venous access\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03634995', 'briefTitle': 'An Investigational Study to Evaluate the Effects of Experimental Medication BMS-986256 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunologic Effects of BMS-986256, and a Relative Bioavailability Study in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM026-002'}, 'secondaryIdInfos': [{'id': '2017-003729-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Dose', 'description': 'Ascending single doses of BMS-986256', 'interventionNames': ['Drug: BMS-986256', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Dose', 'description': 'Ascending multiple doses of BMS-986256', 'interventionNames': ['Drug: BMS-986256', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequential Dose', 'description': 'Sequential multiple doses of BMS-986256', 'interventionNames': ['Drug: BMS-986256', 'Other: Placebo']}], 'interventions': [{'name': 'BMS-986256', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Multiple Dose', 'Sequential Dose', 'Single Dose']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Multiple Dose', 'Sequential Dose', 'Single Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRA Health Science KK', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}