NCT07219030 · AbbVie
A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants
What this study is about
This study is to assess how taken by mouth emraclidine moves through the body of healthy elderly adult participants, and assess side effects, and tolerability.
View original scientific description
This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.
Interventions
DRUG
Emraclidine
Oral tablets
DRUG
Placebo
Oral tablets
Primary outcome measures
Number of Participants Experiencing Adverse Events
Time frame: Up to approximately 50 days
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.
Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements
Time frame: Up to approximately 20 days
Number of participants with clinical significant change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)
Time frame: Up to approximately 20 days
12-lead resting ECG will be recorded.
Number of Participants with Clinical Significant Change in Physical Examinations
Time frame: Up to approximately 20 days
Number of participants with clinical significant change in physical examinations will be assessed.
Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed
Time frame: Up to approximately 20 days
Number of participants with clinical significant change in clinical laboratory test results will be assessed.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 20 days
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.
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to approximately 20 days
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.
Change From Baseline in Barnes Akathisia Rating Scale (BARS)
Time frame: Up to approximately 20 days
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 \[5\]).
Change From Baseline in Simpson-Angus Scale (SAS)
Time frame: Up to approximately 20 days
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.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Up to approximately 20 days
Cmax of Emraclidine
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cmax of Metabolite (CV-0000364)
Time to Cmax (Tmax) of Emraclidine
Time frame: Up to approximately 20 days
Tmax of Emraclidine
Time to Cmax (Tmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Tmax of Metabolite (CV-000036)
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) of Emraclidine
Time frame: Up to approximately 20 days
AUCt of Emraclidine
Area Under the Concentration-Time Curve from Time 0 to Time t (AUCt) Metabolite (CV-000036)
Time frame: Up to approximately 20 days
AUCt of Metabolite (CV-000036)
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time frame: Up to approximately 20 days
AUCtau of Emraclidine
Minimum plasma concentration (Cmin) of Emraclidine
Time frame: Up to approximately 20 days
Cmin of Emraclidine
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cmin of Metabolite (CV-0000364)
Average plasma concentration (Cavg) of Emraclidine
Time frame: Up to approximately 20 days
Cavg of Emraclidine
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
Cavg of Metabolite (CV-0000364)
Metabolite to Parent Ratio (MRCmax) of Emraclidine
Time frame: Up to approximately 20 days
MRCmax of Emraclidine calculated from Cmax
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
MRCmax of Metabolite (CV-0000364) calculated from Cmax
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
Time frame: Up to approximately 20 days
MRAUCtau of Emraclidine based on AUCtau
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
MRAUCtau of Metabolite (CV-000036) based on AUCtau
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Time frame: Up to approximately 20 days
Terminal phase elimination half-life of Emraclidine
Terminal Phase Elimination Half-Life (t1/2) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
Terminal phase elimination half-life of Metabolite (CV-000036)
Apparent terminal phase elimination constant (β) of Emraclidine
Time frame: Up to approximately 20 days
β of Emraclidine
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
β of Metabolite (CV-0000364)
Peak-to-trough ratio (PTR) of Emraclidine
Time frame: Up to approximately 20 days
PTR of Emraclidine
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
Time frame: Up to approximately 20 days
PTR of Metabolite (CV-000036)
Accumulation ratio for Cmax (RacCmax) of Emraclidine
Time frame: Up to approximately 20 days
RacCmax of Emraclidine
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
RacCmax of Metabolite (CV-0000364)
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
Time frame: Up to approximately 20 days
RacAUCtau of Emraclidine
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
RacAUCtau of Metabolite (CV-0000364)
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Time frame: Up to approximately 20 days
CL/F of Emraclidine
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Time frame: Up to approximately 20 days
Vz/F of Emraclidine
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Metabolite (CV-0000364)
Time frame: Up to approximately 20 days
AUCtau of Metabolite (CV-0000364)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- BMI is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- Body weight \> 45 kg at the time of screening and upon initial confinement.
- 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.
Exclusion criteria
- 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.
- History of any clinically significant sensitivity or allergy to any medication or food.
- 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.
Where
- Cypress, California
- Maitland, Florida
- Miami, Florida
- Grayslake, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 12, 2026 · Source of record for eligibility and locations