A Phase 1 interventional study of Emraclidine and Placebo in Healthy Volunteer, sponsored by AbbVie. Recruiting at 5 sites in United States. Open to participants aged 65 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Drug: Emraclidine · Drug: Placebo
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Drug: Emraclidine · Drug: Placebo
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Emraclidine · Drug: Placebo
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Emraclidine · Drug: Placebo
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Emraclidine · Drug: Placebo
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Emraclidine · Drug: Placebo
Oral tablets
Oral tablets
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.
Time frame: Up to approximately 50 days
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.
Time frame: Up to approximately 20 days
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
12-lead resting ECG will be recorded.
Time frame: Up to approximately 20 days
Number of Participants with Clinical Significant Change in Physical Examinations
Number of participants with clinical significant change in physical examinations will be assessed.
Time frame: Up to approximately 20 days
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.
Time frame: Up to approximately 20 days
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.
Time frame: Up to approximately 20 days
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.
Time frame: Up to approximately 20 days
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 \[5\]).
Time frame: Up to approximately 20 days
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.
Time frame: Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Cmax of Emraclidine
Time frame: Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Cmax of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Time to Cmax (Tmax) of Emraclidine
Tmax of Emraclidine
Time frame: Up to approximately 20 days
Time to Cmax (Tmax) of Metabolite (CV-0000364)
Tmax of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
AUCt of Emraclidine
Time frame: Up to approximately 20 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
AUCt of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
AUCtau of Emraclidine
Time frame: Up to approximately 20 days
Minimum plasma concentration (Cmin) of Emraclidine
Cmin of Emraclidine
Time frame: Up to approximately 20 days
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Cmin of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Average plasma concentration (Cavg) of Emraclidine
Cavg of Emraclidine
Time frame: Up to approximately 20 days
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Cavg of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Emraclidine
MRCmax of Emraclidine calculated from Cmax
Time frame: Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
MRCmax of Metabolite (CV-0000364) calculated from Cmax
Time frame: Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
MRAUCtau of Emraclidine based on AUCtau
Time frame: Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
MRAUCtau of Metabolite (CV-000036) based on AUCtau
Time frame: Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Terminal phase elimination half-life of Emraclidine
Time frame: Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
Terminal phase elimination half-life of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Emraclidine
β of Emraclidine
Time frame: Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
β of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Peak-to-trough ratio (PTR) of Emraclidine
PTR of Emraclidine
Time frame: Up to approximately 20 days
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
PTR of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Emraclidine
RacCmax of Emraclidine
Time frame: Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
RacCmax of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
RacAUCtau of Emraclidine
Time frame: Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
RacAUCtau of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
CL/F of Emraclidine
Time frame: Up to approximately 20 days
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Vz/F of Emraclidine
Time frame: Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
AUCtau of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Plan to share: No
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