[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100212024":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":34,"centralContacts":34,"locations":39,"responsibleParty":51,"collaborators":34,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":34,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":34,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":74,"whyStopped":34,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":34,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"FORUM Pharmaceuticals Inc","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: EVP-6308; Arm 1","EXPERIMENTAL","low dose, Capsule, Twice Daily, Day 1 through Day 14",[13],"Drug: Drug: EVP-6308",{"label":15,"type":10,"description":16,"interventionNames":17},"Experimental: EVP-6308; Arm 2","intermediate dose, Capsule, Once Daily, Day 1 through Day 14",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Experimental: EVP-6308; Arm 3","high dose, Capsule, Once Daily, Day 1 through Day 14",[13],{"label":23,"type":24,"description":25,"interventionNames":26},"Placebo Comparator; Arm 4","PLACEBO_COMPARATOR","Placebo, Capsule, Once Daily, Day 1 through Day 14",[27],"Drug: Placebo",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Drug: EVP-6308","Arms 1, 2, 3",[9,15,19],null,{"type":30,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Placebo","Arm 4",[23],[40],{"facility":34,"status":34,"city":41,"state":42,"zip":34,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":34},"Long Beach","California","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.18923,33.76696,{"lat":49,"lon":48},{"type":52,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100212024","phase-1-study-to-assess-the-safety-tolerability-pharmacokinetic-pk-and-pharmacodynamic-pd-effects-of-evp-6308-and-the-potential-of-evp-6308-to-affect-the-pk-properties-of-the-antipsychotic-regimen-in-subjects-with-schizophrenia-currently-receiving-stable-treatment-with-up-to-2-atypical-antipsychotics-100212024",false,"NCT02037074","Study to Assess the Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) Effects of EVP-6308 and the Potential of EVP-6308 to Affect the PK Properties of the Antipsychotic Regimen in Subjects With Schizophrenia Currently Receiving Stable Treatment With up to 2 Atypical Antipsychotics","A Double-Blind, Escalating Dose Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Evaluation of Repeat Doses of EVP-6308 or Placebo in Subjects With Schizophrenia on a Stable Antipsychotic Regimen","Inclusion Criteria:\n\n• Diagnosed with schizophrenia, male or female subjects, 18 to 60 years of age\n\nExclusion Criteria:\n\n* Clinically significant abnormalities on physical examination, medical history, ECG, vital signs, laboratory values, or unstable medical or psychiatric illness\n* Any disorder that may interfere with drug absorption\n* Clinically significant allergy or sensitivity to medications Positive test for human immunodeficiency virus (HIV) antibodies, Hepatitis B surface antigen, or Hepatitis C antibody\n* Pregnant or breast feeding","ALL","18 Years","60 Years",{"count":64,"type":65},40,"ACTUAL","INTERVENTIONAL",[68],"PHASE1","This is a randomized, double-blind, placebo-controlled, sequential cohort, ascending oral dose study of the safety, tolerability, pharmacokinetics, and pharmacodynamics of EVP-6308 administered for 14 days in subjects with schizophrenia who are on a stable anti-psychotic regimen.",[71],"Schizophrenia",[73],"Phosphodiesterase 10 inhibitor","COMPLETED","2015-01-09",{"date":77,"type":78},"2015-01-12","ESTIMATED",{"date":80,"type":34},"2014-06",{"name":5,"class":6},1]