[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643625":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":38,"centralContacts":42,"locations":47,"responsibleParty":70,"collaborators":33,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":33,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":33,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":33,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"H. Lundbeck A\u002FS","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (Single Ascending Dose [SAD] in Healthy Participants): Lu AH69593 or Placebo","EXPERIMENTAL","Participants will receive single oral dose of Lu AH69593 or placebo.",[13,14],"Drug: Lu AH69593","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Part B (Multiple Ascending Dose [MAD] in Healthy Participants): Lu AH69593 or Placebo","Participants will receive Lu AH69593 or placebo orally for 10 days.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Part C (MAD in Participants With Narcolepsy Type 1 [NT1]): Lu AH69593","Participants will receive Lu AH69593 orally for 84 days.",[13],{"label":24,"type":10,"description":25,"interventionNames":26},"Part D (Food Effect in Healthy Participants): Lu AH69593","Participants with receive two single oral doses of Lu AH69593 in fasting or fed condition.",[13],[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Lu AH69593","Lu AH69593 will be administered per schedule specified in the arm description.",[9,16,20,24],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Placebo","Placebo will be administered per schedule specified in the arm description.",[9,16],[39],{"name":40,"affiliation":5,"role":41},"Email contact via H. Lundbeck A\u002FS","STUDY_DIRECTOR",[43],{"name":40,"role":44,"phone":45,"phoneExt":33,"email":46},"CONTACT","+45 36301311","HQ_Medinfo@Lundbeck.com",[48,61],{"facility":49,"status":50,"city":51,"state":33,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":33},"Terveystalo Helsinki, Sleep Clinic","RECRUITING","Helsinki","00380","Finland","FI",{"type":56,"coordinates":57},"Point",[58,59],24.93545,60.16952,{"lat":59,"lon":58},{"facility":62,"status":50,"city":63,"state":33,"zip":64,"country":53,"countryCode":54,"cosmosGeoPoint":65,"geoPoint":69,"contacts":33},"CRST, Clinical Research Services Turku","Turku","20520",{"type":56,"coordinates":66},[67,68],22.26869,60.45148,{"lat":68,"lon":67},{"type":71,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","100643625","phase-1-a-trial-to-test-the-safety-and-tolerability-of-lu-ah69593-in-adults-that-are-healthy-or-have-narcolepsy-100643625",false,"NCT07613710","A Trial to Test the Safety and Tolerability of Lu AH69593 in Adults That Are Healthy or Have Narcolepsy","Interventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single- and Multiple-ascending-dose Trial Investigating Safety, Tolerability, and Pharmacokinetics of Lu AH69593 in Healthy Participants, Including Open-label Cohorts to Explore Pharmacodynamic Properties in Participants With Narcolepsy, and Food Effect in Healthy Participants","Key Inclusion Criteria:\n\nFor all participants in any trial Part (A, B, C and D):\n\n* The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit.\n\nSpecifically for participants in trial Part A, B, and D:\n\n* The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms (kg)\u002Fsquare meter (m\\^2) at the Screening Visit.\n* The participant has a normal circadian rhythm, defined as a person who usually wakes up between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.\n* The participant is ≥18 and ≤55 years of age at the Screening Visit.\n\nSpecifically for participants in trial Part C:\n\n* The participant has a BMI ≥18.5 and ≤35 kg\u002Fm\\^2 at the Screening Visit.\n* The participant has NT1, diagnosed according to International Classification of Sleep Disorders, 3rd edition criteria, with a history of disease diagnosis \\>3 months prior to the Screening Visit.\n* The participant is ≥18 and ≤64 years of age at the Screening Visit.\n\nKey Exclusion Criteria:\n\nFor all participants in any trial Part (A, B, C and D):\n\n* The participant has previously been enrolled in this trial.\n* The participant has previously been dosed with Lu AH69593.\n* The participant has participated in a clinical trial \\\u003C30 days prior to the Screening Visit.\n* The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.\n* The participant has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for \\>5 years prior to the first dose of investigational medicinal product (IMP).\n* The participant has worked shifts, including night duty, or has travelled across \\>3 time zones \\\u003C2 weeks prior to the first dose of IMP.\n* The participant trains\u002Fexercises intensively, for example, for a marathon or triathlon, or at a competitive level.\n\nSpecifically for participants in trial Part A, B and D:\n\n* The participant has had a clinically significant illness from which he\u002Fshe recovered \\\u003C4 weeks prior to the first dose of IMP.\n\nSpecifically for Participants in trial Part B and C:\n\n* The participant is at significant risk of suicide based on medical history, mental status, investigator judgement, or the C-SSRS answer of 'yes' to suicidal ideation question 4 or 5 or 'yes' to suicidal behaviour, within the last 6 months on the C-SSRS at the Screening Visit or 'Since last visit' at the Baseline Visit Day -1.\n\nSpecifically for participants in trial Part C:\n\n* The participant has any other disorder for which the treatment takes priority over treatment of narcolepsy or is likely to interfere with trial treatment or impair treatment compliance.\n* The participant has a current medical disorder, other than NT1, associated with excessive daytime sleepiness (EDS).\n\nNote: Other protocol-defined inclusion and exclusion criteria may apply.",true,"ALL","18 Years","64 Years",{"count":84,"type":85},104,"ESTIMATED","INTERVENTIONAL",[88],"PHASE1","The purpose of the trial is to determine if Lu AH69593 is safe and well tolerated. The trial will also look at how the body processes Lu AH69593 with and without food.",[91],"Narcolepsy","2026-06-08",{"date":94,"type":95},"2026-06-10","ACTUAL",{"date":97,"type":95},"2025-06-13",{"date":99,"type":85},"2026-12-18",{"name":5,"class":6},2]