[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539097":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":41,"studyPopulation":25,"armGroups":42,"interventions":68,"overallOfficials":25,"centralContacts":77,"locations":83,"responsibleParty":98,"collaborators":25,"id":100,"slug":25,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":25,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":25,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":25,"overallStatus":86,"whyStopped":25,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"% Receptor occupancy","Percent change of binding potential from baseline","Day 1",[14,17,20,23,27,30,32],{"measure":15,"description":16,"timeFrame":12},"Pharmacokinetics: AUC0-t","Area under the plasma drug concentration-time curve (AUC) from time zero to the last measurable concentration",{"measure":18,"description":19,"timeFrame":12},"Pharmacokinetics: Cmax","Maximum plasma concentration",{"measure":21,"description":22,"timeFrame":12},"Pharmacokinetics: Tmax","Time of maximum plasma concentration",{"measure":24,"description":25,"timeFrame":26},"Percentage of subjects with treatment-emergent adverse events",null,"Up to 30 days after the dose of study drug",{"measure":28,"description":25,"timeFrame":29},"Change from baseline in ECG QT interval","Day 3",{"measure":31,"description":25,"timeFrame":29},"Change from baseline in aspartate aminotransferase",{"measure":33,"description":25,"timeFrame":29},"Change from baseline in alanine aminotransferase",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":25,"timePerspective":25,"maskingInfo":39},"NON_RANDOMIZED","PARALLEL","This study includes up to 3 sequential parts (Parts A, B and C). In Part A, subjects will be assigned to 1 of 3 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET\u002FCT scan starting at 1 hour postdose.\n\nIn Part B, subjects will be assigned to 1 of 2 cohorts, will receive a single dose of ITI-1284, and undergo one postdose PET\u002FCT scan starting at 1 hour postdose.\n\nIn Part C, subjects will receive a single dose of ITI-1284 and undergo one postdose PET\u002FCT scans starting at approximately 24 hours postdose.","TREATMENT",{"masking":40,"maskingDescription":25,"whoMasked":25},"NONE","This study consists of up to 3 sequential parts. Part A will evaluate the D2 receptor occupancy for ITI-1284 at three dose levels. Part B will evaluate the 5HT-2A receptor and SERT occupancy for ITI-1284 at one dose level. Part C will evaluate the late postdose receptor occupancy of ITI-1284 on the D2 or 5-HT2A receptor at one dose level.",[43,49,53,56,60,64],{"label":44,"type":45,"description":46,"interventionNames":47},"Cohort A1: 10 mg ITI-1284","EXPERIMENTAL","Radioligand: \\[11C\\]-raclopride",[48],"Drug: ITI-1284 10 mg",{"label":50,"type":45,"description":46,"interventionNames":51},"Cohort A2: 20 mg ITI-1284",[52],"Drug: ITI-1284 20 mg",{"label":54,"type":45,"description":46,"interventionNames":55},"Cohort A3: 30 mg ITI-1284",[48,52],{"label":57,"type":45,"description":58,"interventionNames":59},"Cohort B1: 20 mg ITI-1284","Radioligand: \\[11C\\]-MDL100907",[52],{"label":61,"type":45,"description":62,"interventionNames":63},"Cohort B2: 20 mg ITI-1284","Radioligand: \\[11C\\]-DASB",[52],{"label":65,"type":45,"description":66,"interventionNames":67},"Cohort C1: 20 mg ITI-1284","Radioligand: \\[11C\\]-raclopride or \\[11C\\]-MDL100907",[52],[69,74],{"type":70,"name":71,"description":72,"armGroupLabels":73,"otherNames":25},"DRUG","ITI-1284 10 mg","ITI-1284 tablet",[44,54],{"type":70,"name":75,"description":72,"armGroupLabels":76,"otherNames":25},"ITI-1284 20 mg",[50,54,57,61,65],[78],{"name":79,"role":80,"phone":81,"phoneExt":25,"email":82},"ITI Clinical Trials","CONTACT","646 440-9333","ITCIClinicalTrials@itci-inc.com",[84],{"facility":85,"status":86,"city":87,"state":88,"zip":89,"country":90,"countryCode":91,"cosmosGeoPoint":92,"geoPoint":97,"contacts":25},"Clinical Site 1","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":93,"coordinates":94},"Point",[95,96],-72.92816,41.30815,{"lat":96,"lon":95},{"type":99,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100539097",false,"NCT06299410","PET Study to Evaluate Brain Receptor Occupancy, Safety and Pharmacokinetics of ITI-1284 in Healthy Subjects","An Open-label, Positron Emission Tomography Study to Evaluate Brain Receptor Occupancy, Safety, Tolerability, and Pharmacokinetics After a Single Sublingual Administration of ITI-1284 in Healthy Subjects","Inclusion Criteria:\n\n* Healthy male and female subjects between 18 and 55 years old (inclusive);\n* BMI inclusive of 18-32 kg\u002Fm2 at screening and a minimum weight of 50 kg;\n* Willingness to remain in the hospital research unit for the duration of the inpatient period.\n\nExclusion Criteria:\n\n* Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the subject at risk or interfere with study outcome variables; this includes, but is not limited to, history of or current cardiac, hepatic, renal, neurologic, gastrointestinal, pulmonary, endocrinologic, hematologic, or immunologic disease or history of malignancy;\n* Clinically significant abnormal findings in vital sign assessments, supine SBP \\> 140 mmHg or \\\u003C 90 mmHg, or supine DBP \\>90 mmHg or \\\u003C 50 mmHg or supine pulse rate \\> 100 bpm or \\\u003C 45 bpm at Screening;\n* History of psychiatric condition that in the Investigator's opinion may be detrimental to participation in the study;\n* Any condition which would preclude MRI or PET\u002FCT examination (eg, implanted metal, claustrophobia, unable to fit in PET\u002FCT or MRI scanners);\n* Contraindications based on any previous MRI or the study MRI performed prior to the baseline PET\u002FCT scan.",true,"ALL","18 Years","55 Years",{"count":111,"type":112},42,"ESTIMATED","INTERVENTIONAL",[115],"PHASE1","The study will be conducted as an open-label and single-center study to evaluate the occupancy of ITI-1284 to the dopamine D2 receptor, serotonin 2A (5-HT2A) receptor, and serotonin transporter (SERT) in healthy subjects.",[118],"Healthy Volunteers","2026-05-21",{"date":121,"type":122},"2026-05-26","ACTUAL",{"date":124,"type":122},"2024-04-11",{"date":126,"type":112},"2026-07",{"name":5,"class":6},1]