NCT07219030

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
9mo left

Started Oct 2025

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Oct 2025Mar 2027

Study Start

First participant enrolled

October 8, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

1.4 years

First QC Date

October 17, 2025

Last Update Submit

May 7, 2026

Conditions

Healthy Volunteer

Keywords

Healthy VolunteerABBV-1231

Outcome Measures

Primary Outcomes (37)

  • 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.

    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.

    Up to approximately 20 days

  • Number of Participants with Clinical Significant Change from Baseline in Electrocardiogram (ECG)

    12-lead resting ECG will be recorded.

    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.

    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.

    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.

    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.

    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 \[5\]).

    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.

    Up to approximately 20 days

  • Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Cmax of Emraclidine

    Up to approximately 20 days

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

    Cmax of Metabolite (CV-0000364)

    Up to approximately 20 days

  • Time to Cmax (Tmax) of Emraclidine

    Tmax of Emraclidine

    Up to approximately 20 days

  • Time to Cmax (Tmax) of Metabolite (CV-0000364)

    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

    AUCt of Emraclidine

    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)

    Up to approximately 20 days

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

    AUCtau of Emraclidine

    Up to approximately 20 days

  • Minimum plasma concentration (Cmin) of Emraclidine

    Cmin of Emraclidine

    Up to approximately 20 days

  • Minimum plasma concentration (Cmin) of Metabolite (CV-0000364)

    Cmin of Metabolite (CV-0000364)

    Up to approximately 20 days

  • Average plasma concentration (Cavg) of Emraclidine

    Cavg of Emraclidine

    Up to approximately 20 days

  • Average plasma concentration (Cavg) of Metabolite (CV-0000364)

    Cavg of Metabolite (CV-0000364)

    Up to approximately 20 days

  • Metabolite to Parent Ratio (MRCmax) of Emraclidine

    MRCmax of Emraclidine calculated from Cmax

    Up to approximately 20 days

  • Metabolite to Parent Ratio (MRCmax) of Metabolite (CV-0000364)

    MRCmax of Metabolite (CV-0000364) calculated from Cmax

    Up to approximately 20 days

  • Metabolite to Parent Ratio (MRAUCtau) of Emraclidine

    MRAUCtau of Emraclidine based on AUCtau

    Up to approximately 20 days

  • Metabolite to Parent Ratio (MRAUCtau) of Metabolite (CV-000036)

    MRAUCtau of Metabolite (CV-000036) based on AUCtau

    Up to approximately 20 days

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

    Terminal phase elimination half-life of Emraclidine

    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)

    Up to approximately 20 days

  • Apparent terminal phase elimination constant (β) of Emraclidine

    β of Emraclidine

    Up to approximately 20 days

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

    β of Metabolite (CV-0000364)

    Up to approximately 20 days

  • Peak-to-trough ratio (PTR) of Emraclidine

    PTR of Emraclidine

    Up to approximately 20 days

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

    PTR of Metabolite (CV-000036)

    Up to approximately 20 days

  • Accumulation ratio for Cmax (RacCmax) of Emraclidine

    RacCmax of Emraclidine

    Up to approximately 20 days

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

    RacCmax of Metabolite (CV-0000364)

    Up to approximately 20 days

  • Accumulation ratio for AUCtau (RacAUCtau) of Emraclidine

    RacAUCtau of Emraclidine

    Up to approximately 20 days

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

    RacAUCtau of Metabolite (CV-0000364)

    Up to approximately 20 days

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

    CL/F of Emraclidine

    Up to approximately 20 days

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

    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)

    AUCtau of Metabolite (CV-0000364)

    Up to approximately 20 days

Study Arms (5)

Emraclidine or Placebo- Group 1

EXPERIMENTAL

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Drug: EmraclidineDrug: Placebo

Emraclidine or Placebo- Group 2

EXPERIMENTAL

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days

Drug: EmraclidineDrug: Placebo

Emraclidine or Placebo- Group 3

EXPERIMENTAL

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Drug: EmraclidineDrug: Placebo

Emraclidine or Placebo- Group 4

EXPERIMENTAL

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Drug: EmraclidineDrug: Placebo

Emraclidine or Placebo- Group 5

EXPERIMENTAL

Participants will receive oral doses of emraclidine or placebo for 10 days or 17 days.

Drug: EmraclidineDrug: Placebo

Interventions

EmraclidineDRUG

Oral tablets

Emraclidine or Placebo- Group 1Emraclidine or Placebo- Group 2Emraclidine or Placebo- Group 3Emraclidine or Placebo- Group 4Emraclidine or Placebo- Group 5
PlaceboDRUG

Oral tablets

Emraclidine or Placebo- Group 1Emraclidine or Placebo- Group 2Emraclidine or Placebo- Group 3Emraclidine or Placebo- Group 4Emraclidine or Placebo- Group 5

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Altasciences Clinical Los Angeles /ID# 276854

Cypress, California, 90630, United States

RECRUITING

K2 Medical Research, LLC /ID# 276636

Maitland, Florida, 32751, United States

RECRUITING

Clinical Pharmacology Of Miami /ID# 276856

Miami, Florida, 33172, United States

RECRUITING

Acpru /Id# 276996

Grayslake, Illinois, 60030, United States

RECRUITING

Related Links

Study Officials

  • ABBVIE INC.

    AbbVie

    STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742abbvieclinicaltrials@abbvie.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2025

First Posted

October 21, 2025

Study Start

October 8, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(4)