protocolSection identificationModule nctId: NCT06362642, orgStudyIdInfo id: PMV-586-105, briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-28, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: PMV Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: The treatments will be: Day 1: single oral dose of PC14586, Day 20: oral dose of itraconazole BID, Day 21-22: single oral dose of itraconazole QD, Day 23: single oral dose of PC14586 and single oral dose of itraconazole, Day 24-27: single oral dose of itraconazole QD., primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 16, type: ESTIMATED, armsInterventionsModule interventions name: PC14586, interventions name: Itraconazole, outcomesModule primaryOutcomes measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 when co-administered with itraconazole in healthy participants., primaryOutcomes measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the total drug exposure from time zero to the last timepoint (AUC0-t) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., secondaryOutcomes measure: Identification of laboratory abnormalities based on hematology and clinical chemistry after administration of PC14586 alone and when co-administered with itraconazole in healthy participants., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Fortrea, status: RECRUITING, city: Madison, state: Wisconsin, zip: 53704, country: United States, contacts name: Christine Hale, MD, role: CONTACT, email: Christine.Hale@fortrea.com, geoPoint lat: 43.07305, lon: -89.40123, hasResults: False