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

A Phase 1, Open-label, Single Dose, Crossover Study to Assess the Relative Bioavailability of Emraclidine Formulations in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07587008

Enrollment

Registered

2026-05-14

Start date

2026-05-12

Completion date

2026-07-17

Last updated

2026-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers, Emraclidine

Brief 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.

Interventions

DRUGEmraclidine

Oral tablet

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants with Adverse Events (AEs)	Up to approximately 44 days	An adverse event (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. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine	Up to approximately 14 days	Cmax of Emraclidine.
Time to Cmax (Tmax) of Emraclidine	Up to approximately 14 days	Tmax of Emraclidine.
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine	Up to approximately 14 days	AUC of Emraclidine.

Countries

United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 15, 2026