Nctid:
NCT06227975
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>8}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-02", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-05", "completionDateStruct"=>{"date"=>"2024-04-03", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-05-10", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-05-13", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-04-03", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Maximum observed concentration (Cmax)", "timeFrame"=>"Up to Day 15"}, {"measure"=>"Time of maximum observed concentration (Tmax)", "timeFrame"=>"Up to Day 15"}, {"measure"=>"Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))", "timeFrame"=>"Up to Day 15"}, {"measure"=>"Total Radioactivity (TRA)", "timeFrame"=>"Up to Day 30"}], "secondaryOutcomes"=>[{"measure"=>"Number of participants with Adverse Events (AEs)", "timeFrame"=>"Up to Day 36"}, {"measure"=>"Number of participants with Serious AEs (SAEs)", "timeFrame"=>"Up to Day 36"}, {"measure"=>"Number of participants with AEs leading to discontinuation", "timeFrame"=>"Up to Day 36"}, {"measure"=>"Number of participants with vital sign abnormalities", "timeFrame"=>"Up to Day 30"}, {"measure"=>"Number of participants with electrocardiogram (ECG) abnormalities", "timeFrame"=>"Up to Day 30"}, {"measure"=>"Number of participants with physical examination abnormalities", "timeFrame"=>"Up to Day 30"}, {"measure"=>"Number of participants with clinical laboratory test abnormalities", "timeFrame"=>"Up to Day 30"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["ADME", "Healthy male volunteers", "Pharmacokinetics", "BMS-986368", "CC-97489"], "conditions"=>["Healthy Volunteers"]}, "referencesModule"=>{"seeAlsoLinks"=>[{"url"=>"https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html", "label"=>"BMS Clinical Trial Information"}]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"55 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.\n* Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\\[m\\])\\^2\n\nExclusion Criteria:\n\n* History of hypokalemia.\n* Any significant acute or chronic medical illness as determined by the investigator.\n* Participant has a history of syncope in the year prior to Day 1.\n\nOther protocol-defined incusion/exclusion criteria apply."}, "identificationModule"=>{"nctId"=>"NCT06227975", "briefTitle"=>"A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Celgene"}, "officialTitle"=>"A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants", "orgStudyIdInfo"=>{"id"=>"IM045-1003"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"[14C]-BMS-986368", "interventionNames"=>["Drug: [14C]-BMS-986368"]}], "interventions"=>[{"name"=>"[14C]-BMS-986368", "type"=>"DRUG", "otherNames"=>["CC-97489"], "description"=>"Specified dose on specified days", "armGroupLabels"=>["[14C]-BMS-986368"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"53704-2526", "city"=>"Madison", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"Local Institution - 0001", "geoPoint"=>{"lat"=>43.07305, "lon"=>-89.40123}}], "overallOfficials"=>[{"name"=>"Bristol-Myers Squibb", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Bristol-Myers Squibb"}]}, "ipdSharingStatementModule"=>{"url"=>"https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", "infoTypes"=>["STUDY_PROTOCOL", "SAP", "CSR"], "timeFrame"=>"See plan description", "ipdSharing"=>"YES", "description"=>"BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html", "accessCriteria"=>"See plan description"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Celgene", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
