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

NCT07587008 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: M26-506
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Emraclidine

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (6)

Sequence 1

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 1.

Drug: Emraclidine

Sequence 2

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 2.

Drug: Emraclidine

Sequence 3

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 3.

Drug: Emraclidine

Sequence 4

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 4.

Drug: Emraclidine

Sequence 5

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 5.

Drug: Emraclidine

Sequence 6

EXPERIMENTAL

Participants will receive Emraclidine in 3 different formulations in Sequence 6.

Drug: Emraclidine

Interventions

Emraclidine DRUG

Oral tablet

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Body mass index of 18.5 to 32.0 kg/m2, inclusive.
• Total body weight \>= 50 kg.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share