[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"narcolepsy-type-1-nt1\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:narcolepsy-type-1-nt1":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":21,"type":22},118,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Narcolepsy Type 1 (NT1)","RECRUITING","2026-06-04",{"date":32,"type":33},"2026-06-08","ACTUAL",{"date":35,"type":33},"2026-05-21",{"date":37,"type":22},"2027-03-05",{"name":39,"class":40},"Vertex Pharmaceuticals Incorporated","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100620907","phase-3-a-trial-of-tak-861-for-the-treatment-of-narcolepsy-with-cataplexy-100620907","NCT07363720","A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy","A Double-blind, Placebo-Controlled, Randomized Withdrawal Trial to Evaluate the Efficacy and Safety of TAK-861 for the Treatment of Narcolepsy With Cataplexy (Narcolepsy Type 1)","Inclusion Criteria:\n\n1. The participant has a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg\u002Fm\\^2).\n2. The participant has an International Classification of Sleep Disorders, Third Edition (ICSD-3) or International Classification of Sleep Disorders, Third Edition, Text Revision (ICSD-3-TR) diagnosis of NT1.\n3. The participant is positive for the human leukocyte antigen (HLA) genotype Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1\\*06:02) or results from radioimmunoassay indicate the participant's CSF OX\u002Fhypocretin-1 concentration is ≤110 pg\u002FmL (or less than one-third of the mean values obtained in normal participants within the same standardized assay).\n\nExclusion Criteria:\n\n1. The participant has a current medical disorder, other than narcolepsy with cataplexy, associated with EDS.\n2. The participant a) has a history of myocardial infarction, b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure, or c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease.\n3. The participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs.\n4. The participant has a history of cancer in the past 5 years.\n5. The participant has a clinically significant history of head injury or head trauma.\n6. The participant has a history of epilepsy, seizure, or convulsion (except for a single febrile seizure in childhood).\n7. The participant has a history of cerebral ischemia, transient ischemic attack (less than 5 years from screening), intracranial aneurysm, or arteriovenous malformation.","16 Years","70 Years",{"count":52,"type":22},88,[54],"PHASE3","The main aim of this study is to assess how effective TAK-861 is for treating narcolepsy type 1 and if this effect is maintained over time. Participants will take TAK-861 for a few months and if they meet certain criteria, they will be randomly assigned (by chance, like flipping a coin) to continue taking TAK-861 or take placebo (fake medicine) for up to 4 weeks to see if their narcolepsy symptoms return.",[28,57],"Narcolepsy With Cataplexy",[59],"Drug Therapy","2026-05-07",{"date":62,"type":33},"2026-05-08",{"date":64,"type":33},"2026-01-29",{"date":66,"type":22},"2026-10-02",{"name":68,"class":40},"Takeda",18]