RecruitingPhase 1

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

United States12 participantsStarted 2026-05-12

Plain-language summary

The objective of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of emraclidine following single oral administration of different immediate-release (IR) tablet formulations in healthy adult participants.

Who can participate

Age range

18 Years – 55 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: * Body mass index of 18.5 to 32.0 kg/m2, inclusive. * Total body weight \>= 50 kg. Exclusion Criteria: * History of suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement. * Vital sign measurements, at Screening and Check-in: * Systolic blood pressure \>= 140 mmHg or \< 100 mmHg * Diastolic blood pressure \>= 90 mmHg or \< 60 mmHg * Heart rate \> 100 bpm or \< 50 bpm * Orthostatic hypotension, defined as a decrease of \>= 20 mmHg in systolic blood pressure upon standing compared with the supine/sitting blood pressure measurement. * Female participants of childbearing potential

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 with Adverse Events (AEs)

Timeframe: Up to approximately 44 days

Maximum Observed Plasma Concentration (Cmax) of Emraclidine

Timeframe: Up to approximately 14 days

Time to Cmax (Tmax) of Emraclidine

Timeframe: Up to approximately 14 days

Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine

Timeframe: Up to approximately 14 days

Trial details

NCT IDNCT07587008

SponsorAbbVie

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range

18 Years – 55 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 with Adverse Events (AEs)

Timeframe: Up to approximately 44 days

Maximum Observed Plasma Concentration (Cmax) of Emraclidine

Timeframe: Up to approximately 14 days

Time to Cmax (Tmax) of Emraclidine

Timeframe: Up to approximately 14 days

Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine

Timeframe: Up to approximately 14 days