[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614759":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":44,"centralContacts":59,"locations":65,"responsibleParty":80,"collaborators":44,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":44,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":44,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":44,"overallStatus":68,"whyStopped":44,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8,14,20,24,28,34],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Single Ascending Dose","EXPERIMENTAL","Participants will be randomized to receive a single dose of VX-581.",[13],"Drug: VX-581",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo: Part A","PLACEBO_COMPARATOR","Participants will be randomized to receive a single dose of placebo matched to VX-581.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B: Multiple Ascending Dose","Participants will be randomized to receive multiple doses of VX-581.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Placebo: Part B","Participants will be randomized to receive multiple doses of placebo matched to VX-581.",[19],{"label":29,"type":10,"description":30,"interventionNames":31},"Part C: VX-581 with TEZ\u002FD-IVA or D-IVA","Participants will be randomized to receive multiple doses VX-581 in combination with TEZ\u002FD-IVA or D-IVA.",[13,32,33],"Drug: D-IVA","Drug: TEZ",{"label":35,"type":16,"description":36,"interventionNames":37},"Placebo: Part C","Participants will be randomized to receive placebo matched to VX-581 in combination with TEZ\u002FD-IVA or D-IVA.",[19,32,33],[39,45,48,54],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","VX-581","Suspension for Oral Administration.",[9,21,29],null,{"type":40,"name":46,"description":42,"armGroupLabels":47,"otherNames":44},"Placebo",[15,25,35],{"type":40,"name":49,"description":50,"armGroupLabels":51,"otherNames":52},"D-IVA","Tablet for Oral Administration.",[29,35],[53],"deutivacaftor",{"type":40,"name":55,"description":50,"armGroupLabels":56,"otherNames":57},"TEZ",[29,35],[58],"tezacaftor",[60],{"name":61,"role":62,"phone":63,"phoneExt":44,"email":64},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[66],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":44},"Altasciences - Kansas City","RECRUITING","Overland Park","Kansas","66212","United States","US",{"type":75,"coordinates":76},"Point",[77,78],-94.67079,38.98223,{"lat":78,"lon":77},{"type":81,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100614759","phase-1-dose-escalation-study-evaluating-the-safety-and-pharmacokinetics-of-vx-581-in-healthy-participants-100614759",false,"NCT07283770","Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-581 in Healthy Participants","A Phase 1, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-581 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)\n* A total body weight of more than (\\>) 50 kg\n* Male and Female participants of non-childbearing potential\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\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","55 Years",{"count":94,"type":95},136,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single dose of VX-581 and multiple ascending doses of VX-581 alone and in combination with tezacaftor (TEZ)\u002Fdeutivacaftor (D-IVA) or D-IVA for up to ten days.",[101],"Cystic Fibrosis","2026-07-14",{"date":104,"type":105},"2026-07-16","ACTUAL",{"date":107,"type":105},"2025-12-09",{"date":109,"type":95},"2026-11-19",{"name":5,"class":6},1]