[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558959":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":50,"locations":56,"responsibleParty":139,"collaborators":29,"id":141,"slug":142,"hasResults":143,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":29,"eligibilityCriteria":147,"healthyVolunteers":143,"sex":148,"minAge":149,"maxAge":150,"enrollmentInfo":151,"targetDuration":29,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":29,"overallStatus":82,"whyStopped":29,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 (10 to less than 13 years)","EXPERIMENTAL","Lumateperone capsule once daily: 10.5 mg on Days 1 and 2; 10.5 mg or 21 mg on Day 3; 10.5 mg or 21 mg on Days 4 and 5",[13,14],"Drug: Lumateperone 10.5 mg capsule","Drug: Lumateperone 21 mg capsule",{"label":16,"type":10,"description":17,"interventionNames":18},"Group 2 (5 to less than 10 years)","Lumateperone ODT once daily: 5 mg on Days 1 and 2; 5 mg or 10.5 mg on Day 3; 5 mg or 10.5 mg on Days 4 and 5; dosing regimen may be adjusted after the first 6 patients dosed and will not exceed 21 mg in subsequent patients",[19,20,21,22],"Drug: Lumateperone 5 mg ODT","Drug: Lumateperone 10.5 mg ODT","Drug: Lumateperone 15.5 mg ODT","Drug: Lumateperone 21 mg ODT",[24,30,34,38,42,46],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Lumateperone 10.5 mg capsule","Lumateperone 10.5 mg capsule, oral administration",[9],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Lumateperone 21 mg capsule","Lumateperone 21 mg capsule, oral 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5","Lincoln","Nebraska","68526",{"type":66,"coordinates":125},[126,127],-96.66696,40.8,{"lat":127,"lon":126},{"facility":130,"status":82,"city":131,"state":132,"zip":133,"country":63,"countryCode":64,"cosmosGeoPoint":134,"geoPoint":138,"contacts":29},"Clinical Site 8","Everett","Washington","98201",{"type":66,"coordinates":135},[136,137],-122.20208,47.97898,{"lat":137,"lon":136},{"type":140,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100558959","phase-1-safety-tolerability-and-pharmacokinetics-of-lumateperone-in-pediatric-patients-with-autism-spectrum-disorder-100558959",false,"NCT06557902","Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder","An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder","Inclusion Criteria:\n\n* Male or female patients between 5 to less than 13 years of age\n* Primary clinical diagnosis of ASD with symptoms of irritability\n* ABC-I subscale score of ≥12 at Screening\n* CGI-S score of ≥3 at Screening\n* Body mass index (BMI) greater than the 5th percentile according to age- and gender-specific CDC Clinical Growth Charts (2000) at Screening\n* Ability to swallow capsules\n\nExclusion Criteria:\n\n* Has a primary psychiatric diagnosis other than ASD\n* Reports suicidal ideation (Type 3, 4 or 5 on the Baseline\u002FScreening version of the C-SSRS) within 6 months prior to Screening, or any suicidal behavior within 2 years prior to Screening, and\u002For the Investigator assesses the patient to be a safety risk to him\u002Fherself or others\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables\n* History of a clinically significant cardiac disorder and\u002For abnormal screening ECG or a QT interval corrected for heart rate using Fridericia formula (QTcF) \\> 460 msec at Screening\n* Patients with a history of orthostatic hypotension or who have orthostatic hypotension at Screening\n* Has a history of uncontrolled\u002Fdisruptive behavior in the past 30 days that, in the Investigator's opinion, would preclude the ability to participate in study procedures","ALL","5 Years","12 Years",{"count":152,"type":153},26,"ESTIMATED","INTERVENTIONAL",[156],"PHASE1","Study ITI-007-035 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone for pediatric patients with Autism Spectrum Disorder.",[159],"Autism Spectrum Disorder","2024-08-14",{"date":162,"type":163},"2024-08-16","ACTUAL",{"date":165,"type":163},"2024-05-10",{"date":167,"type":153},"2026-07-31",{"name":5,"class":6},8]