[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222191":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":29,"locations":38,"responsibleParty":49,"collaborators":29,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":29,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":29,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":74,"whyStopped":29,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Janssen Research & Development, LLC","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A","EXPERIMENTAL","3 to 5 participants will undergo Positron Emission Tomography (PET)\u002Fcomputed tomography scan after administration of 11C-MK-3168 on Day 1.",[13],"Drug: 11C-MK-3168",{"label":15,"type":10,"description":16,"interventionNames":17},"Part B","3 to 12 participants will undergo PET scan after administration of 11C-MK-3168 on Day 1. Participants will receive 2 single doses of JNJ-42165279: 100 mg on Days 1 and up to 250 mg on Day 8. Participants will undergo PET scans after 1 hour of each administration of JNJ-42165279 on Days 1 and 8, with 11C-MK-3168 administration.",[18,13],"Drug: JNJ-42165279",{"label":20,"type":10,"description":21,"interventionNames":22},"Part C","4 to 8 participants will undergo PET scan after administration of 11C-MK-3168 on Day 1. Participants will receive once daily dose of JNJ-42165279 (up to 100 mg) from Day 1 to Day 7. Participants will undergo PET scans after 24 hour of administration of JNJ-42165279 on Days 1 and 7, with 11C-MK-3168 administration.",[18,13],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","JNJ-42165279","Participants will receive oral suspension of JNJ-42165279 in Part B as single dose on Day 1 (100 mg) and on Day 8 (up to 250 mg); in Part C as once daily dose (up to 100 mg) from Day 1 to Day 7.",[15,20],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"11C-MK-3168","Participants will receive 11C-MK-3168 in the target range of 185 to 370 megabecquerel (MBq) intravenously (into a vein) before every positron emission tomography scan in Parts A, B, and C.",[9,15,20],[35],{"name":36,"affiliation":5,"role":37},"Janssen Research & Development, LLC Clinical Trial","STUDY_DIRECTOR",[39],{"facility":29,"status":29,"city":40,"state":29,"zip":29,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":29},"Leuven","Belgium","BE",{"type":44,"coordinates":45},"Point",[46,47],4.70093,50.87959,{"lat":47,"lon":46},{"type":50,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100222191","phase-1-a-study-to-investigate-the-regional-brain-kinetics-of-the-positron-emission-tomography-ligand-11c-mk-3168-and-the-blocking-of-the-retention-of-the-ligand-in-the-human-brain-by-jnj-42165279-100222191",false,"NCT02169973","A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279","An Open-Label Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand 11C-MK-3168 and the Blocking of the Retention of the Ligand in the Human Brain by JNJ-42165279","Inclusion Criteria:\n\n* Body mass index (BMI) between 18 and 30 kg\u002Fm2 inclusive (BMI = weight\u002Fheight2)\n* Non-smoker (not smoked for 3 months prior to screening)\n* Agree to use one of the protocol mentioned barrier methods of birth control\n\nExclusion Criteria:\n\n* Exposed to 1 millisievert or more of ionizing radiation in the year before the start of this study\n* Clinically significant abnormal laboratory values and abnormal physical and neurological examination at screening\n* Any clinically significant Magnetic Resonance Imaging (MRI) abnormalities at screening, as determined by a neuroradiologist, which are relevant for the study\n* Allen test (test to assess the arterial blood flow to the hand) indicating abnormal blood supply to the hand\n* Has implanted or embedded metal objects, or fragments in the head or body that would present a risk during the MRI scanning procedure",true,"MALE","18 Years","55 Years",{"count":63,"type":64},15,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","The purpose of the study is to measure the uptake, distribution, and clearance of 11C-MK-3168 by Positron Emission Tomography (PET) scan and to model the tissue specific kinetics of 11C-MK-3168 with the appropriate input function in human brain in Part A; to measure blocking of retention of 11C-MK-3168 at the estimated time to maximum plasma concentration after dosing (tmax) following each single oral doses of JNJ-42165279 and model the exposure\u002Fenzyme interaction of JNJ-42165279 in Part B; to measure the saturation of enzyme inhibition in the brain at steady state plasma concentrations of JNJ-42165279 (on Day 8) after 7 once-daily doses of JNJ-42165279 by conducting PET studies with 11C-MK-3168 at trough plasma concentrations on Day 2 in Part C.",[70],"Healthy",[70,72,31,26,73],"Positron Emission Tomography","Human Brain","COMPLETED","2015-09-25",{"date":77,"type":78},"2015-09-28","ESTIMATED",{"date":80,"type":29},"2014-02",{"date":82,"type":64},"2014-07",{"name":5,"class":6},1]