[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643784":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":39,"centralContacts":51,"locations":57,"responsibleParty":72,"collaborators":39,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":39,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":39,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":39,"overallStatus":60,"whyStopped":39,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Vertex Pharmaceuticals Incorporated","INDUSTRY",[8,14,20,24,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A: Single Ascending Dose (SAD)","EXPERIMENTAL","Participants will be randomized to receive a single dose of VX-433.",[13],"Drug: VX-433",{"label":15,"type":16,"description":17,"interventionNames":18},"Part A: Placebo","PLACEBO_COMPARATOR","Participants will be randomized to receive placebo matched to VX-433.",[19],"Drug: Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B: Multiple Ascending Dose (MAD)","Participants will be randomized to receive multiple doses of VX-433.",[13],{"label":25,"type":16,"description":17,"interventionNames":26},"Part B: Placebo",[19],{"label":28,"type":10,"description":29,"interventionNames":30},"Part C: Drug Drug Interaction","Participants will receive a single dose of midazolam and bupropion on Day 1 in Dosing Period 1, followed by VX-433 administration for 17 days (Days 5 through 21) and then midazolam and bupropion on Day 18 in Dosing Period 2.\n\nPart C will be open-label.",[13,31,32],"Drug: Midazolam","Drug: Bupropion",[34,40,43,47],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","VX-433","Suspension for Oral Administration",[9,21,28],null,{"type":35,"name":41,"description":37,"armGroupLabels":42,"otherNames":39},"Placebo",[15,25],{"type":35,"name":44,"description":45,"armGroupLabels":46,"otherNames":39},"Midazolam","Syrup for Oral Administration",[28],{"type":35,"name":48,"description":49,"armGroupLabels":50,"otherNames":39},"Bupropion","Capsule for Oral Administration",[28],[52],{"name":53,"role":54,"phone":55,"phoneExt":39,"email":56},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[58],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":39},"ICON - Utah - Salt Lake City Office","RECRUITING","Salt Lake City","Utah","84124","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-111.89105,40.76078,{"lat":70,"lon":69},{"type":73,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100643784","phase-1-a-phase-1-first-in-human-study-of-vx-433-100643784",false,"NCT07584434","A Phase 1, First-in-human Study of VX-433","A Phase 1, First-in-human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VX-433 and Its Effects on the Pharmacokinetics of Midazolam and Bupropion","Key Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg\u002Fm2), inclusive\n* A total body weight of more than (\\>) 50 kg\n* Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening\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* For female participants: of childbearing potential, pregnant, breastfeeding, or planning to become pregnant or donate ova during the study or within 90 days after last dose of study drug\n\nOther protocol defined Inclusion\u002FExclusion criteria will apply.",true,"ALL","18 Years","55 Years",{"count":86,"type":87},118,"ESTIMATED","INTERVENTIONAL",[90],"PHASE1","The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of VX-433 following single and multiple ascending doses, as well as to assess the effect of VX-433 on the PK of midazolam, bupropion, and hydroxybupropion.",[93],"Narcolepsy Type 1 (NT1)","2026-06-04",{"date":96,"type":97},"2026-06-08","ACTUAL",{"date":99,"type":97},"2026-05-21",{"date":101,"type":87},"2027-03-05",{"name":5,"class":6},1]