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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Emraclidine

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Participants will receive Emraclidine in 3 different formulations in Sequence 1.	Drug: Emraclidine; Oral tablet
Experimental: Sequence 2; Participants will receive Emraclidine in 3 different formulations in Sequence 2.	Drug: Emraclidine; Oral tablet
Experimental: Sequence 3; Participants will receive Emraclidine in 3 different formulations in Sequence 3.	Drug: Emraclidine; Oral tablet
Experimental: Sequence 4; Participants will receive Emraclidine in 3 different formulations in Sequence 4.	Drug: Emraclidine; Oral tablet
Experimental: Sequence 5; Participants will receive Emraclidine in 3 different formulations in Sequence 5.	Drug: Emraclidine; Oral tablet
Experimental: Sequence 6; Participants will receive Emraclidine in 3 different formulations in Sequence 6.	Drug: Emraclidine; Oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	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.	Up to approximately 44 days
Maximum Observed Plasma Concentration (Cmax) of Emraclidine	Cmax of Emraclidine.	Up to approximately 14 days
Time to Cmax (Tmax) of Emraclidine	Tmax of Emraclidine.	Up to approximately 14 days
Area Under the Concentration-Time Curve from Time 0 to Time t (AUC) of Emraclidine	AUC of Emraclidine.	Up to approximately 14 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Study record dates

Study Major Dates

• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: May 8, 2026
• First Submitted That Met QC Criteria: May 8, 2026
• First Posted (Actual): May 14, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Emraclidine
• Other Study ID Numbers: M26-506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No