RecruitingPhase 1

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

United States40 participantsStarted 2025-10-08

Plain-language summary

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

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Experiencing Adverse Events

Timeframe: Up to approximately 50 days

Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements

Timeframe: Up to approximately 20 days

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

Timeframe: Up to approximately 20 days

Number of Participants with Clinical Significant Change in Physical Examinations

Timeframe: Up to approximately 20 days

Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed

Timeframe: Up to approximately 20 days

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to approximately 20 days

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)

Trial details

NCT IDNCT07219030

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

View on ClinicalTrials.gov More Healthy Volunteer trials

Who can participate

Age range

65 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Experiencing Adverse Events

Timeframe: Up to approximately 50 days

Number of Participants with Clinical Significant Change From Baseline in Vital Sign Measurements

Timeframe: Up to approximately 20 days

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

Timeframe: Up to approximately 20 days

Number of Participants with Clinical Significant Change in Physical Examinations

Timeframe: Up to approximately 20 days

Number of Participants with Clinical Significant Change in Clinical Laboratory Test Results Like Hematology will be Assessed

Timeframe: Up to approximately 20 days

Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Timeframe: Up to approximately 20 days

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)