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OpenTrials
Active, Not Recruiting

NCT Number: NCT07587008

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 283349

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emraclidine

Drug

Oral tablet

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: 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.

  2. Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Time frame: Up to approximately 14 days

    Cmax of Emraclidine.

  3. Time to Cmax (Tmax) of Emraclidine

    Time frame: Up to approximately 14 days

    Tmax of Emraclidine.

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

    Time frame: Up to approximately 14 days

    AUC of Emraclidine.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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