[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628138":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":64,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":39,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":39,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":48,"whyStopped":39,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Yale University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Control - Test\u002FRetest","EXPERIMENTAL","In Part 1 we will conduct a test\u002Fretest study of the novel GABA Transporter (GAT-1) imaging tracer \\[18F\\]GATT44 in humans, to characterize its pharmacokinetic behavior and determine the reliability and reproducibility of in vivo pharmacokinetic parameter measurements",[13],"Drug: [ 18F]GATT-44",{"label":15,"type":10,"description":16,"interventionNames":17},"Healthy Control - Test-Blocking","In Part 2, we will conduct a test-blocking study to assess specific binding levels of \\[18F\\]GATT44 in humans.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Healthy Control - Whole Body","In Part 3, human dosimetry of \\[18F\\]GATT44 will be estimated by performing whole-body imaging studies",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","[ 18F]GATT-44","First in human radiotracer being evaluated in this study.",[15,9,19],[29],"[18F]GAT44",[31],{"name":32,"affiliation":5,"role":33},"Richard E Carson, PhD","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Shannan Henry","CONTACT","+1 (203) 737-5278",null,"shannan.henry@yale.edu",{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},"Kayla R Cottiers","203-737-7496","kayla.cottiers@yale.edu",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Yale University PET Center","RECRUITING","New Haven","Connecticut","06519","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-72.92816,41.30815,{"lat":58,"lon":57},[61,62,63],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},{"name":42,"role":37,"phone":43,"phoneExt":39,"email":44},{"name":32,"role":33,"phone":39,"phoneExt":39,"email":39},{"type":33,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"Richard Carson","Professor of Radiology and Biomedical Imaging and of Biomedical Engineering",[68],{"name":69,"class":70},"National Institute of Mental Health (NIMH)","NIH","100628138","early-phase-1-evaluation-of-18fgatt-44-for-positron-emission-tomography-imaging-of-the-gaba-transporter-1-100628138",false,"NCT07457736","Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1","Inclusion Criteria:\n\n1. Willing and able to give voluntary written informed consent;\n2. Able to read and write, able to communicate effectively with the investigator, and comply with all study requirements, restrictions, and directions of the research staff;\n3. Male or female, aged 18 to 60, at screening;\n4. In good general health as evidenced by medical history, physical examination, ECG, serum\u002Furine biochemistry, hematology, and serology tests;\n5. Females of childbearing potential, and male subjects, must be willing to practice birth control for the duration of the study (unless medical documentation is provided confirming subject is permanently sterile).\n\nExclusion:\n\n1. Less than 18 years of age;\n2. Pregnant or breastfeeding;\n3. Any significant systemic illness or unstable medical condition;\n4. Pre-existing medical conditions or claustrophobic reactions;\n5. Research-related radiation exposure exceeds current PET Center guidelines;\n6. History of a bleeding disorder or are currently taking anticoagulants.",true,"ALL","18 Years","60 Years",{"count":82,"type":83},32,"ESTIMATED","INTERVENTIONAL",[86],"EARLY_PHASE1","Evaluate \\[18F\\]GATT-44 (aka \\[18F\\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \\[18F\\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \\[18F\\]GATT-44 by performing whole-body imaging studies.",[89],"Healthy Adult Participants",[91,92,93,94,95],"gatt44","experimental radiotracer","first in human radiotracer","GAT-1","GATT-44","2026-08-18",{"date":98,"type":99},"2026-08-20","ACTUAL",{"date":101,"type":99},"2026-01-28",{"date":103,"type":83},"2030-01",{"name":5,"class":6},1]