[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659634":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":70,"studyPopulation":11,"armGroups":71,"interventions":78,"overallOfficials":11,"centralContacts":83,"locations":11,"responsibleParty":89,"collaborators":11,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":11,"eligibilityCriteria":97,"healthyVolunteers":98,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":11,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":11,"overallStatus":111,"whyStopped":11,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":11},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":46,"otherOutcomes":11},[9,13,16,18,20,22,24,26,28,30,32,34,36,38,40,42,44],{"measure":10,"description":11,"timeFrame":12},"Amount of Radioactivity Excreted (Ae) of 14C-VX-407 Total Radioactivity (TRA) in Urine, and Feces",null,"From Day -1 up to Day 30",{"measure":14,"description":11,"timeFrame":15},"Terminal Phase Rate Constant (λz) of VX-407 in Plasma","From Day 1 up to Day 30",{"measure":17,"description":11,"timeFrame":15},"Area Under the Concentration Versus Time Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-tlast) of VX-407 in Plasma",{"measure":19,"description":11,"timeFrame":15},"Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407 in Plasma",{"measure":21,"description":11,"timeFrame":15},"Apparent Clearance (CL\u002FF) of VX-407 in Plasma",{"measure":23,"description":11,"timeFrame":12},"Renal Clearance (CLr) of VX-407",{"measure":25,"description":11,"timeFrame":15},"Maximum Observed Plasma Concentration (Cmax) of VX-407 in Plasma",{"measure":27,"description":11,"timeFrame":15},"Time for VX-407 to Reach Maximum Concentration (Tmax) of VX-407 in Plasma and Urine",{"measure":29,"description":11,"timeFrame":12},"Fraction (percent) of Dose Excreted Unchanged in Urine of VX-407 (fe)",{"measure":31,"description":11,"timeFrame":15},"Apparent Volume of Distribution (Vz\u002FF) (Based on the Terminal Phase) of VX-407 in Plasma",{"measure":33,"description":11,"timeFrame":15},"Terminal Phase Rate Constant (λz) of Total Radioactivity (TRA) in Whole blood and Plasma",{"measure":35,"description":11,"timeFrame":15},"AUC0-tlast of TRA in Whole blood and Plasma",{"measure":37,"description":11,"timeFrame":15},"AUC0-inf of TRA in Whole blood and Plasma",{"measure":39,"description":11,"timeFrame":15},"CL\u002FF of TRA in Whole blood and Plasma",{"measure":41,"description":11,"timeFrame":15},"Cmax of TRA in Whole blood and Plasma",{"measure":43,"description":11,"timeFrame":12},"Fraction (percent) of Dose Excreted Unchanged in Urine of TRA",{"measure":45,"description":11,"timeFrame":15},"Apparent Volume of Distribution (Based on the Terminal Phase) of TRA in Whole blood and Plasma",[47,49,51,53,55,57,59,61],{"measure":48,"description":11,"timeFrame":15},"Metabolite Profiling and Identification in Plasma, Urine, and Feces",{"measure":50,"description":11,"timeFrame":15},"Terminal Phase Rate Constant (λz) of VX-407 Metabolites in Plasma",{"measure":52,"description":11,"timeFrame":15},"AUC0-tlast of VX-407 Metabolites in Plasma",{"measure":54,"description":11,"timeFrame":15},"AUC0-inf of VX-407 Metabolites in Plasma",{"measure":56,"description":11,"timeFrame":15},"Cmax of VX-407 Metabolites in Plasma",{"measure":58,"description":11,"timeFrame":15},"Tmax of VX-407 Metabolites in Plasma",{"measure":60,"description":11,"timeFrame":15},"Apparent Volume of Distribution (Based on the Terminal Phase) of VX-407 Metabolites in Plasma",{"measure":62,"description":11,"timeFrame":63},"Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","Day 1 up to Day 41",{"allocation":65,"interventionModel":66,"interventionModelDescription":11,"primaryPurpose":67,"observationalModel":11,"timePerspective":11,"maskingInfo":68},"NA","SINGLE_GROUP","TREATMENT",{"masking":69,"maskingDescription":11,"whoMasked":11},"NONE","The purpose of the study is to evaluate the pharmacokinetics of VX-407 following a single oral dose. This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).",[72],{"label":73,"type":74,"description":75,"interventionNames":76},"14C-VX-407","EXPERIMENTAL","Participants will receive a single oral dose of 14C-VX-407 after an overnight fast of at least 8 hours.",[77],"Drug: 14C-VX-407",[79],{"type":80,"name":73,"description":81,"armGroupLabels":82,"otherNames":11},"DRUG","Solution for Oral Administration.",[73],[84],{"name":85,"role":86,"phone":87,"phoneExt":11,"email":88},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",{"type":90,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659634","phase-1-absorption-distribution-metabolism-and-excretion-of-14c-vx-407-after-a-single-oral-dose-100659634",false,"NCT07868926","Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose","A Phase 1, Open-Label, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 Following Single Oral Administration in Healthy Subjects","Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg\u002Fm\\^2), inclusive\n* A total body weight of more than (\\>) 50 kg\n* Participants must have regular bowel movements (i.e., average of more than or equal to (\\>=) 1 and less than or equal to (\\\u003C=)3 stools per day)\n\nKey Exclusion Criteria:\n\n* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug\n* Any condition possibly affecting drug absorption, distribution, metabolism, or excretion\n* Exposure to any nonenvironmental radiation (e.g., diagnostic medical imaging or occupational exposure) within 12 months before study drug administration\n* Participation in more than 1 radiolabeled study (if the previous study's radiation exposure is unknown) or participation in more than 3 radiolabeled studies (if the previous studies' radiation exposure is known) in the 12 months before dosing or if the annual whole-body radiation exposure from all previous studies (including this dosing) is more than the FDA-allowed maximum whole body radiation exposure of 5000 mrem\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.",true,"MALE","19 Years","55 Years",{"count":103,"type":104},8,"ESTIMATED","INTERVENTIONAL",[107],"PHASE1","The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of VX-407 following a single oral dose.",[110],"Autosomal Dominant Polycystic Kidney Disease (ADPKD)","NOT_YET_RECRUITING","2026-10-05",{"date":114,"type":115},"2026-10-09","ACTUAL",{"date":117,"type":104},"2026-10-19",{"date":119,"type":104},"2026-12-15",{"name":5,"class":6}]