[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100539097":3},{"organization":4,"armGroups":7,"interventions":33,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":64,"collaborators":39,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":39,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":39,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":39,"overallStatus":52,"whyStopped":39,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Intra-Cellular Therapies, Inc.","INDUSTRY",[8,14,18,21,25,29],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort A1: 10 mg ITI-1284","EXPERIMENTAL","Radioligand: \\[11C\\]-raclopride",[13],"Drug: ITI-1284 10 mg",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort A2: 20 mg ITI-1284",[17],"Drug: ITI-1284 20 mg",{"label":19,"type":10,"description":11,"interventionNames":20},"Cohort A3: 30 mg ITI-1284",[13,17],{"label":22,"type":10,"description":23,"interventionNames":24},"Cohort B1: 20 mg ITI-1284","Radioligand: \\[11C\\]-MDL100907",[17],{"label":26,"type":10,"description":27,"interventionNames":28},"Cohort B2: 20 mg ITI-1284","Radioligand: \\[11C\\]-DASB",[17],{"label":30,"type":10,"description":31,"interventionNames":32},"Cohort C1: 20 mg ITI-1284","Radioligand: \\[11C\\]-raclopride or \\[11C\\]-MDL100907",[17],[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"DRUG","ITI-1284 10 mg","ITI-1284 tablet",[9,19],null,{"type":35,"name":41,"description":37,"armGroupLabels":42,"otherNames":39},"ITI-1284 20 mg",[15,19,22,26,30],[44],{"name":45,"role":46,"phone":47,"phoneExt":39,"email":48},"ITI Clinical Trials","CONTACT","646 440-9333","ITCIClinicalTrials@itci-inc.com",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":39},"Clinical Site 1","RECRUITING","New Haven","Connecticut","06520","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-72.92816,41.30815,{"lat":62,"lon":61},{"type":65,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100539097","phase-1-pet-study-to-evaluate-brain-receptor-occupancy-safety-and-pharmacokinetics-of-iti-1284-in-healthy-subjects-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":78,"type":79},42,"ESTIMATED","INTERVENTIONAL",[82],"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.",[85],"Healthy Volunteers","2026-05-21",{"date":88,"type":89},"2026-05-26","ACTUAL",{"date":91,"type":89},"2024-04-11",{"date":93,"type":79},"2026-07",{"name":5,"class":6},1]