[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07584434":3,"trial-entities:NCT07584434":127,"trial-summary:NCT07584434":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":50,"secondary_outcomes":66,"sex":92,"minimum_age":93,"maximum_age":94,"healthy_volunteers":95,"eligibility_criteria":96,"std_ages":106,"locations":108,"central_contacts":118,"overall_officials":124,"references":125,"see_also_links":126},"NCT07584434","VX25-433-001","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","RECRUITING","2027-03-05","2026-05","2026-06-08","2026-05-21","Vertex Pharmaceuticals Incorporated","INDUSTRY",null,"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.","The study is being conducted in healthy participants to evaluate the safety, tolerability, and PK of VX-433 (Parts A and B), as well as potential drug-drug interaction (DDI) between VX-433 and midazolam or bupropion (Part C).\n\nNote: 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.).",[19],"Narcolepsy Type 1 (NT1)",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE1",{"count":26,"type":27},118,"ESTIMATED",[29,37,42,46],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","VX-433","Suspension for Oral Administration",[34,35,36],"Part A: Single Ascending Dose (SAD)","Part B: Multiple Ascending Dose (MAD)","Part C: Drug Drug Interaction",{"type":30,"name":38,"description":32,"armGroupLabels":39},"Placebo",[40,41],"Part A: Placebo","Part B: Placebo",{"type":30,"name":43,"description":44,"armGroupLabels":45},"Midazolam","Syrup for Oral Administration",[36],{"type":30,"name":47,"description":48,"armGroupLabels":49},"Bupropion","Capsule for Oral Administration",[36],[51,54,57,60,62,64],{"measure":52,"timeFrame":53},"Part A: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 up to Day 6",{"measure":55,"timeFrame":56},"Part B: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 up to Day 18",{"measure":58,"timeFrame":59},"Part C: Maximum Observed Plasma Concentration (Cmax) of Midazolam in the Absence and Presence of VX-433","From Day 1 up to Day 22",{"measure":61,"timeFrame":59},"Part C: Maximum Observed Plasma Concentration (Cmax) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433",{"measure":63,"timeFrame":59},"Part C: Area Under the Concentration Versus Time Curve (AUC) of Midazolam in the Absence and Presence of VX-433",{"measure":65,"timeFrame":59},"Part C: Area Under the Concentration Versus Time Curve (AUC) of Bupropion and Hydroxybupropion in the Absence and Presence of VX-433",[67,69,71,73,75,77,79,82,85,87,89],{"measure":68,"timeFrame":53},"Part A: Maximum Observed Plasma Concentration (Cmax) of VX-433",{"measure":70,"timeFrame":56},"Part B: Maximum Observed Plasma Concentration (Cmax) of VX-433",{"measure":72,"timeFrame":53},"Part A: Area Under the Concentration Versus Time Curve (AUC) of VX-433",{"measure":74,"timeFrame":56},"Part B: Area Under the Concentration Versus Time Curve (AUC) of VX-433",{"measure":76,"timeFrame":53},"Part A: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1\u002F2)",{"measure":78,"timeFrame":56},"Part B: Time Required for Plasma Concentration of VX-433 to Reduce to Half (t1\u002F2)",{"measure":80,"timeFrame":81},"Part A: Renal Clearance (CLr) of VX-433","From Day 1 up to Day 2",{"measure":83,"timeFrame":84},"Part B: Renal Clearance (CLr) of VX-433","From Day 1 up to Day 11",{"measure":86,"timeFrame":81},"Part A: Amount of VX-433 excreted in Urine",{"measure":88,"timeFrame":84},"Part B: Amount of VX-433 excreted in Urine",{"measure":90,"timeFrame":91},"Part C: Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)","From Day 1 up to Day 29","ALL","18 Years","55 Years",true,{"inclusion":97,"exclusion":101,"raw_text":105},[98,99,100],"Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg\u002Fm2), inclusive","A total body weight of more than (\\>) 50 kg","Nonsmoker or ex-smoker for at least 3 months before screening with current nonsmoking status confirmed by urine or blood cotinine at screening",[102,103,104],"History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug","Any condition possibly affecting drug absorption","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","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.",[107],"ADULT",[109],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"geoPoint":115},"ICON - Utah - Salt Lake City Office","Salt Lake City","Utah","84124","United States",{"lat":116,"lon":117},40.76078,-111.89105,[119],{"name":120,"role":121,"phone":122,"email":123},"Medical Information","CONTACT","617-341-6777","medicalinfo@vrtx.com",[],[],[],{"nct_id":4,"conditions":128,"biomarkers":130},[129],"Narcolepsy type 1",[],{"nct_id":4,"found":132,"summary":15,"prompt_version":15},false]