A Study to Assess the Adverse Events and How Oral Emraclidine Moves Through the Body of Healthy Elderly Adult Participants

May 7, 2026 updated by: AbbVie

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

This study is to assess how oral emraclidine moves through the body of healthy elderly adult participants, and assess adverse events, and tolerability.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Recruiting
        • Altasciences Clinical Los Angeles /ID# 276854
    • Florida
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research, LLC /ID# 276636
      • Miami, Florida, United States, 33172
        • Recruiting
        • Clinical Pharmacology Of Miami /ID# 276856
        • Contact:
          • Site Coordinator
          • Phone Number: 786-493-9466
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Recruiting
        • Acpru /Id# 276996
        • Contact:
          • Site Coordinator
          • Phone Number: 847-935-4400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Emraclidine or Placebo- Group 1
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Drug: Placebo
Oral tablets
Drug: Emraclidine
Oral tablets
Experimental: Emraclidine or Placebo- Group 2
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days
Drug: Placebo
Oral tablets
Drug: Emraclidine
Oral tablets
Experimental: Emraclidine or Placebo- Group 3
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Placebo
Oral tablets
Drug: Emraclidine
Oral tablets
Experimental: Emraclidine or Placebo- Group 4
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Placebo
Oral tablets
Drug: Emraclidine
Oral tablets
Experimental: Emraclidine or Placebo- Group 5
Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.
Drug: Placebo
Oral tablets
Drug: Emraclidine
Oral tablets

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 50 days
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.
Up to approximately 20 days
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.
Up to approximately 20 days
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.
Up to approximately 20 days
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.
Up to approximately 20 days
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.
Up to approximately 20 days
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]).
Up to approximately 20 days
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.
Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time Frame: Up to approximately 20 days
Cmax of Emraclidine
Up to approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
Cmax of Metabolite (CV-0000364)
Up to approximately 20 days
Time to Cmax (Tmax) of Emraclidine
Time Frame: Up to approximately 20 days
Tmax of Emraclidine
Up to approximately 20 days
Time to Cmax (Tmax) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
Tmax of Metabolite (CV-000036)
Up to approximately 20 days
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
Up to approximately 20 days
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)
Up to approximately 20 days
Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine
Time Frame: Up to approximately 20 days
AUCtau of Emraclidine
Up to approximately 20 days
Minimum plasma concentration (Cmin) of Emraclidine
Time Frame: Up to approximately 20 days
Cmin of Emraclidine
Up to approximately 20 days
Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
Cmin of Metabolite (CV-0000364)
Up to approximately 20 days
Average plasma concentration (Cavg) of Emraclidine
Time Frame: Up to approximately 20 days
Cavg of Emraclidine
Up to approximately 20 days
Average plasma concentration (Cavg) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
Cavg of Metabolite (CV-0000364)
Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Emraclidine
Time Frame: Up to approximately 20 days
MRCmax of Emraclidine calculated from Cmax
Up to approximately 20 days
Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
MRCmax of Metabolite (CV-0000364) calculated from Cmax
Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Emraclidine
Time Frame: Up to approximately 20 days
MRAUCtau of Emraclidine based on AUCtau
Up to approximately 20 days
Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)
Time Frame: Up to approximately 20 days
MRAUCtau of Metabolite (CV-000036) based on AUCtau
Up to approximately 20 days
Terminal Phase Elimination Half-Life (t1/2) of Emraclidine
Time Frame: Up to approximately 20 days
Terminal phase elimination half-life of Emraclidine
Up to approximately 20 days
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)
Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Emraclidine
Time Frame: Up to approximately 20 days
β of Emraclidine
Up to approximately 20 days
Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
β of Metabolite (CV-0000364)
Up to approximately 20 days
Peak-to-trough ratio (PTR) of Emraclidine
Time Frame: Up to approximately 20 days
PTR of Emraclidine
Up to approximately 20 days
Peak-to-trough ratio (PTR) of Metabolite (CV-000036)
Time Frame: Up to approximately 20 days
PTR of Metabolite (CV-000036)
Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Emraclidine
Time Frame: Up to approximately 20 days
RacCmax of Emraclidine
Up to approximately 20 days
Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
RacCmax of Metabolite (CV-0000364)
Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine
Time Frame: Up to approximately 20 days
RacAUCtau of Emraclidine
Up to approximately 20 days
Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)
Time Frame: Up to approximately 20 days
RacAUCtau of Metabolite (CV-0000364)
Up to approximately 20 days
Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine
Time Frame: Up to approximately 20 days
CL/F of Emraclidine
Up to approximately 20 days
Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine
Time Frame: Up to approximately 20 days
Vz/F of Emraclidine
Up to approximately 20 days
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)
Up to approximately 20 days
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.
Up to approximately 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M25-904

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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