nctId: NCT06362642 id: PMV-586-105 briefTitle: A Study to Investigate the Effects of Itraconazole on the Pharmacokinetics of PC14586 in Healthy Participants overallStatus: RECRUITING date: 2024-03-28 date: 2024-08 date: 2024-12 date: 2024-04-12 date: 2024-04-12 name: PMV Pharmaceuticals, Inc class: INDUSTRY briefSummary: The purpose of this study is to assess the effect of PC14586 pharmacokinetics when co administered with itraconazole in healthy participants. conditions: Healthy Volunteers studyType: INTERVENTIONAL phases: PHASE1 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 masking: NONE count: 16 type: ESTIMATED name: PC14586 name: Itraconazole measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure from time zero to 24 hours (AUC0-24) of PC14586 when co-administered with itraconazole in healthy participants. 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. measure: Characterize the half-life (t1/2) of PC14586 when co-administered with itraconazole in healthy participants. measure: Characterize the Maximum Plasma Concentration (Cmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the total drug exposure (AUC0-inf) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Characterize the time to peak drug concentration (Tmax) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. 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. 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. measure: Characterize the half-life (t1/2) of PC14586 metabolites M13 and M14 when co-administered with itraconazole in healthy participants. measure: Identification of the incidence of treatment emergent adverse events (TEAE) of PC14586 when administered alone and co-administered with itraconazole in healthy participants. measure: Identification of vital sign abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. measure: Identification of 12-lead electrocardiogram (ECG) abnormalities after administration of PC14586 alone and when co-administered with itraconazole in healthy participants. 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. sex: ALL minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT facility: Fortrea status: RECRUITING city: Madison state: Wisconsin zip: 53704 country: United States name: Christine Hale, MD role: CONTACT email: Christine.Hale@fortrea.com lat: 43.07305 lon: -89.40123 hasResults: False