[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609780":3},{"organization":4,"outcomesModule":7,"designInfo":123,"detailedDescription":122,"studyPopulation":122,"armGroups":134,"interventions":158,"overallOfficials":167,"centralContacts":171,"locations":177,"responsibleParty":242,"collaborators":122,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":122,"eligibilityCriteria":250,"healthyVolunteers":251,"sex":252,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":122,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":194,"whyStopped":122,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"AbbVie","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":122,"otherOutcomes":122},[9,13,17,20,23,26,29,32,35,38,41,44,47,50,53,56,59,62,65,68,71,74,77,80,83,86,89,92,95,98,101,104,107,110,113,116,119],{"measure":10,"description":11,"timeFrame":12},"Number of Participants Experiencing Adverse Events","An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.","Up to approximately 50 days",{"measure":14,"description":15,"timeFrame":16},"Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements","Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.","Up to approximately 20 days",{"measure":18,"description":19,"timeFrame":16},"Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)","12-lead resting ECG will be recorded.",{"measure":21,"description":22,"timeFrame":16},"Number of Participants with Clinical Significant Change in Physical Examinations","Number of participants with clinical significant change in physical examinations will be assessed.",{"measure":24,"description":25,"timeFrame":16},"Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed","Number of participants with clinical significant change in clinical laboratory test results will be assessed.",{"measure":27,"description":28,"timeFrame":16},"Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)","The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.",{"measure":30,"description":31,"timeFrame":16},"Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)","AIMS assesses abnormal involuntary movements, such as tardive dyskinesia, associated with antipsychotic drugs; it measures facial, oral, extremities, and trunk movements, as well as the participant's awareness of abnormal movements. The first 10 items are rated on a none (0) to severe (4) scale. There are an additional 2 items on dental status that are answered yes or no.",{"measure":33,"description":34,"timeFrame":16},"Change From Baseline in Barnes Akathisia Rating Scale (BARS)","BARS is a 4-item rating scale used to assess drug-induced akathisia. The scale comprises items for rating the observable restless movements that characterize the condition, the subjective awareness of restlessness, and any distress associated with the akathisia (each on a 4-point scale from normal \\[0\\] to severe \\[3\\]). In addition, there is a global severity for akathisia rated on a 6-point scale (absent \\[0\\] to severe akathisia \\[5\\]).",{"measure":36,"description":37,"timeFrame":16},"Change From Baseline in Simpson-Angus Scale (SAS)","SAS is a 10-item rating scale for assessment of antipsychotic-induced parkinsonism in both clinical practice and research settings. Each item ranges from 0 (normal) to 4 (extreme symptoms). The scale consists of 1 item measuring gait (hypokinesia), 6 items measuring rigidity, and 3 items measuring glabella tap, tremor, and salivation, respectively.",{"measure":39,"description":40,"timeFrame":16},"Maximum Observed Plasma Concentration (Cmax) of Emraclidine","Cmax of Emraclidine",{"measure":42,"description":43,"timeFrame":16},"Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)","Cmax of Metabolite (CV-0000364)",{"measure":45,"description":46,"timeFrame":16},"Time to Cmax (Tmax) of Emraclidine","Tmax of Emraclidine",{"measure":48,"description":49,"timeFrame":16},"Time to Cmax (Tmax) of Metabolite (CV-0000364)","Tmax of Metabolite (CV-000036)",{"measure":51,"description":52,"timeFrame":16},"Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine","AUCt of Emraclidine",{"measure":54,"description":55,"timeFrame":16},"Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)","AUCt of Metabolite (CV-000036)",{"measure":57,"description":58,"timeFrame":16},"Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine","AUCtau of Emraclidine",{"measure":60,"description":61,"timeFrame":16},"Minimum plasma concentration (Cmin) of Emraclidine","Cmin of Emraclidine",{"measure":63,"description":64,"timeFrame":16},"Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)","Cmin of Metabolite (CV-0000364)",{"measure":66,"description":67,"timeFrame":16},"Average plasma concentration (Cavg) of Emraclidine","Cavg of Emraclidine",{"measure":69,"description":70,"timeFrame":16},"Average plasma concentration (Cavg) of Metabolite (CV-0000364)","Cavg of Metabolite (CV-0000364)",{"measure":72,"description":73,"timeFrame":16},"Metabolite to Parent Ratio (MRCmax) of Emraclidine","MRCmax of Emraclidine calculated from Cmax",{"measure":75,"description":76,"timeFrame":16},"Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)","MRCmax of Metabolite (CV-0000364) calculated from Cmax",{"measure":78,"description":79,"timeFrame":16},"Metabolite to Parent Ratio (MRAUCtau) of Emraclidine","MRAUCtau of Emraclidine based on AUCtau",{"measure":81,"description":82,"timeFrame":16},"Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)","MRAUCtau of Metabolite (CV-000036) based on AUCtau",{"measure":84,"description":85,"timeFrame":16},"Terminal Phase Elimination Half-Life (t1\u002F2) of Emraclidine","Terminal phase elimination half-life of Emraclidine",{"measure":87,"description":88,"timeFrame":16},"Terminal Phase Elimination Half-Life (t1\u002F2) of Metabolite (CV-000036)","Terminal phase elimination half-life of Metabolite (CV-000036)",{"measure":90,"description":91,"timeFrame":16},"Apparent terminal phase elimination constant (β) of Emraclidine","β of Emraclidine",{"measure":93,"description":94,"timeFrame":16},"Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)","β of Metabolite (CV-0000364)",{"measure":96,"description":97,"timeFrame":16},"Peak-to-trough ratio (PTR) of Emraclidine","PTR of Emraclidine",{"measure":99,"description":100,"timeFrame":16},"Peak-to-trough ratio (PTR) of Metabolite (CV-000036)","PTR of Metabolite (CV-000036)",{"measure":102,"description":103,"timeFrame":16},"Accumulation ratio for Cmax (RacCmax) of Emraclidine","RacCmax of Emraclidine",{"measure":105,"description":106,"timeFrame":16},"Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)","RacCmax of Metabolite (CV-0000364)",{"measure":108,"description":109,"timeFrame":16},"Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine","RacAUCtau of Emraclidine",{"measure":111,"description":112,"timeFrame":16},"Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)","RacAUCtau of Metabolite (CV-0000364)",{"measure":114,"description":115,"timeFrame":16},"Apparent Clearance of Drug from Plasma (CL\u002FF) of Emraclidine","CL\u002FF of Emraclidine",{"measure":117,"description":118,"timeFrame":16},"Apparent Volume of Distribution DuringTerminal Phase (Vz\u002FF) of Emraclidine","Vz\u002FF of Emraclidine",{"measure":120,"description":121,"timeFrame":16},"Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)","AUCtau of Metabolite (CV-0000364)",null,{"allocation":124,"interventionModel":125,"interventionModelDescription":122,"primaryPurpose":126,"observationalModel":122,"timePerspective":122,"maskingInfo":127},"RANDOMIZED","SEQUENTIAL","BASIC_SCIENCE",{"masking":128,"maskingDescription":122,"whoMasked":129},"QUADRUPLE",[130,131,132,133],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[135,142,145,149,152,155],{"label":136,"type":137,"description":138,"interventionNames":139},"Emraclidine or Placebo- Group 1","EXPERIMENTAL","Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days",[140,141],"Drug: Emraclidine","Drug: Placebo",{"label":143,"type":137,"description":138,"interventionNames":144},"Emraclidine or Placebo- Group 2",[140,141],{"label":146,"type":137,"description":147,"interventionNames":148},"Emraclidine or Placebo- Group 3","Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.",[140,141],{"label":150,"type":137,"description":147,"interventionNames":151},"Emraclidine or Placebo- Group 4",[140,141],{"label":153,"type":137,"description":147,"interventionNames":154},"Emraclidine or Placebo- Group 5",[140,141],{"label":156,"type":137,"description":147,"interventionNames":157},"Emraclidine or Placebo- Group 6",[140,141],[159,164],{"type":160,"name":161,"description":162,"armGroupLabels":163,"otherNames":122},"DRUG","Emraclidine","Oral tablets",[136,143,146,150,153,156],{"type":160,"name":165,"description":162,"armGroupLabels":166,"otherNames":122},"Placebo",[136,143,146,150,153,156],[168],{"name":169,"affiliation":5,"role":170},"ABBVIE INC.","STUDY_DIRECTOR",[172],{"name":173,"role":174,"phone":175,"phoneExt":122,"email":176},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[178,192,203,216,229],{"facility":179,"status":180,"city":181,"state":182,"zip":183,"country":184,"countryCode":185,"cosmosGeoPoint":186,"geoPoint":191,"contacts":122},"Altasciences Clinical Los Angeles \u002FID# 276854","COMPLETED","Cypress","California","90630","United States","US",{"type":187,"coordinates":188},"Point",[189,190],-118.03729,33.81696,{"lat":190,"lon":189},{"facility":193,"status":194,"city":195,"state":196,"zip":197,"country":184,"countryCode":185,"cosmosGeoPoint":198,"geoPoint":202,"contacts":122},"K2 Medical Research, LLC \u002FID# 276636","RECRUITING","Maitland","Florida","32751",{"type":187,"coordinates":199},[200,201],-81.36312,28.62778,{"lat":201,"lon":200},{"facility":204,"status":194,"city":205,"state":196,"zip":206,"country":184,"countryCode":185,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"Clinical Pharmacology Of Miami \u002FID# 276856","Miami","33172",{"type":187,"coordinates":208},[209,210],-80.19366,25.77427,{"lat":210,"lon":209},[213],{"name":214,"role":174,"phone":215,"phoneExt":122,"email":122},"Site Coordinator","786-493-9466",{"facility":217,"status":194,"city":218,"state":219,"zip":220,"country":184,"countryCode":185,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Acpru \u002FId# 276996","Grayslake","Illinois","60030",{"type":187,"coordinates":222},[223,224],-88.04175,42.34447,{"lat":224,"lon":223},[227],{"name":214,"role":174,"phone":228,"phoneExt":122,"email":122},"847-935-4400",{"facility":230,"status":194,"city":231,"state":232,"zip":233,"country":184,"countryCode":185,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"Hassman Research Institute Marlton Site \u002FID# 276876","Marlton","New Jersey","08053",{"type":187,"coordinates":235},[236,237],-74.92183,39.89122,{"lat":237,"lon":236},[240],{"name":214,"role":174,"phone":241,"phoneExt":122,"email":122},"888-437-4104",{"type":243,"investigatorFullName":122,"investigatorTitle":122,"investigatorAffiliation":122,"oldNameTitle":122,"oldOrganization":122},"SPONSOR","100609780","phase-1-a-study-to-assess-the-adverse-events-and-how-oral-emraclidine-moves-through-the-body-of-healthy-elderly-adult-participants-100609780",false,"NCT07219030","A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants","A Phase 1, Randomized, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Emraclidine Following Multiple Ascending Oral Doses in Healthy Elderly Subjects","Inclusion Criteria:\n\n* BMI is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Body weight \\> 45 kg at the time of screening and upon initial confinement.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* History of any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, genitourinary, immunological, hematologic, neurological or psychiatric disease or disorder, or any other uncontrolled medical illness.\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.",true,"ALL","65 Years","85 Years",{"count":256,"type":257},52,"ESTIMATED","INTERVENTIONAL",[260],"PHASE1","This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.",[263],"Healthy Volunteer",[263,265],"ABBV-1231","2026-09-11",{"date":268,"type":269},"2026-09-15","ACTUAL",{"date":271,"type":269},"2025-10-08",{"date":273,"type":257},"2026-12",{"name":5,"class":6},5]