[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07587008":3,"trial-entities:NCT07587008":92,"trial-summary:NCT07587008":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":40,"secondary_outcomes":55,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":73,"locations":75,"central_contacts":85,"overall_officials":86,"references":90,"see_also_links":91},"NCT07587008","M26-506","Study to Assess Adverse Events and How Oral Emraclidine Moves Through the Body of Adult Healthy Volunteers","A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects","COMPLETED","2026-07-17","2026-08","2026-08-14","2026-05-12","AbbVie","INDUSTRY",false,"The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.",null,[19],"Healthy Volunteers",[19,21],"Emraclidine","INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE1",{"count":27,"type":28},12,"ACTUAL",[30],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Oral tablet",[34,35,36,37,38,39],"Sequence 1","Sequence 2","Sequence 3","Sequence 4","Sequence 5","Sequence 6",[41,45,49,52],{"measure":42,"description":43,"timeFrame":44},"Number of Participants with Adverse Events (AEs)","An adverse event (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. The investigator assesses the relationship of each event to the use of study.","Up to approximately 44 days",{"measure":46,"description":47,"timeFrame":48},"Maximum Observed Plasma Concentration (Cmax) of Emraclidine","Cmax of Emraclidine.","Up to approximately 14 days",{"measure":50,"description":51,"timeFrame":48},"Time to Cmax (Tmax) of Emraclidine","Tmax of Emraclidine.",{"measure":53,"description":54,"timeFrame":48},"Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine","AUC of Emraclidine.",[],"ALL","18 Years","55 Years",true,{"inclusion":61,"exclusion":64,"raw_text":72},[62,63],"Body mass index of 18.5 to 32.0 kg\u002Fm2, inclusive.","Total body weight \\>= 50 kg.",[65,66,67,68,69,70,71],"History of suicidal ideation within one year prior to study treatment administration and\u002For history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any \"yes\" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.","Vital sign measurements, at Screening and Check-in:","Systolic blood pressure \\>= 140 mmHg or \\\u003C 100 mmHg","Diastolic blood pressure \\>= 90 mmHg or \\\u003C 60 mmHg","Heart rate \\> 100 bpm or \\\u003C 50 bpm","Orthostatic hypotension, defined as a decrease of \\>= 20 mmHg in systolic blood pressure upon standing compared with the supine\u002Fsitting blood pressure measurement.","Female participants of childbearing potential","Inclusion Criteria:\n\n* Body mass index of 18.5 to 32.0 kg\u002Fm2, inclusive.\n* Total body weight \\>= 50 kg.\n\nExclusion Criteria:\n\n* History of suicidal ideation within one year prior to study treatment administration and\u002For history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any \"yes\" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.\n* Vital sign measurements, at Screening and Check-in:\n\n  * Systolic blood pressure \\>= 140 mmHg or \\\u003C 100 mmHg\n  * Diastolic blood pressure \\>= 90 mmHg or \\\u003C 60 mmHg\n  * Heart rate \\> 100 bpm or \\\u003C 50 bpm\n  * Orthostatic hypotension, defined as a decrease of \\>= 20 mmHg in systolic blood pressure upon standing compared with the supine\u002Fsitting blood pressure measurement.\n* Female participants of childbearing potential",[74],"ADULT",[76],{"facility":77,"city":78,"state":79,"zip":80,"country":81,"geoPoint":82},"Acpru \u002FId# 283349","Grayslake","Illinois","60030","United States",{"lat":83,"lon":84},42.34447,-88.04175,[],[87],{"name":88,"affiliation":13,"role":89},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":93,"biomarkers":94},[19],[],{"nct_id":4,"found":15,"summary":17,"prompt_version":17}]