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NCT Number: NCT07219030

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

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

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Key information

Conditions

Healthy Volunteer

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles /ID# 276854, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Emraclidine

Drug

Oral tablets

Placebo

Drug

Oral tablets

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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]).

  9. 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.

  10. Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Time frame: Up to approximately 20 days

    Cmax of Emraclidine

  11. Maximum Observed Plasma Concentration (Cmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    Cmax of Metabolite (CV-0000364)

  12. Time to Cmax (Tmax) of Emraclidine

    Time frame: Up to approximately 20 days

    Tmax of Emraclidine

  13. Time to Cmax (Tmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    Tmax of Metabolite (CV-000036)

  14. 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

  15. 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)

  16. Area under the plasma concentration-time curve over the dosing interval (AUCtau) of Emraclidine

    Time frame: Up to approximately 20 days

    AUCtau of Emraclidine

  17. Minimum plasma concentration (Cmin) of Emraclidine

    Time frame: Up to approximately 20 days

    Cmin of Emraclidine

  18. Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    Cmin of Metabolite (CV-0000364)

  19. Average plasma concentration (Cavg) of Emraclidine

    Time frame: Up to approximately 20 days

    Cavg of Emraclidine

  20. Average plasma concentration (Cavg) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    Cavg of Metabolite (CV-0000364)

  21. Metabolite to Parent Ratio (MRCmax) of Emraclidine

    Time frame: Up to approximately 20 days

    MRCmax of Emraclidine calculated from Cmax

  22. Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    MRCmax of Metabolite (CV-0000364) calculated from Cmax

  23. Metabolite to Parent Ratio (MRAUCtau) of Emraclidine

    Time frame: Up to approximately 20 days

    MRAUCtau of Emraclidine based on AUCtau

  24. Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)

    Time frame: Up to approximately 20 days

    MRAUCtau of Metabolite (CV-000036) based on AUCtau

  25. Terminal Phase Elimination Half-Life (t1/2) of Emraclidine

    Time frame: Up to approximately 20 days

    Terminal phase elimination half-life of Emraclidine

  26. 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)

  27. Apparent terminal phase elimination constant (β) of Emraclidine

    Time frame: Up to approximately 20 days

    β of Emraclidine

  28. Apparent terminal phase elimination constant (β) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    β of Metabolite (CV-0000364)

  29. Peak-to-trough ratio (PTR) of Emraclidine

    Time frame: Up to approximately 20 days

    PTR of Emraclidine

  30. Peak-to-trough ratio (PTR) of Metabolite (CV-000036)

    Time frame: Up to approximately 20 days

    PTR of Metabolite (CV-000036)

  31. Accumulation ratio for Cmax (RacCmax) of Emraclidine

    Time frame: Up to approximately 20 days

    RacCmax of Emraclidine

  32. Accumulation ratio for Cmax (RacCmax) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    RacCmax of Metabolite (CV-0000364)

  33. Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine

    Time frame: Up to approximately 20 days

    RacAUCtau of Emraclidine

  34. Accumulation ratio for AUCtau (RacAUCtau) of Metabolite (CV-0000364)

    Time frame: Up to approximately 20 days

    RacAUCtau of Metabolite (CV-0000364)

  35. Apparent Clearance of Drug from Plasma (CL/F) of Emraclidine

    Time frame: Up to approximately 20 days

    CL/F of Emraclidine

  36. Apparent Volume of Distribution DuringTerminal Phase (Vz/F) of Emraclidine

    Time frame: Up to approximately 20 days

    Vz/F of Emraclidine

  37. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

ABBVIE CALL CENTER

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 21, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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