Skip to main content
OpenTrials
Completed

NCT Number: NCT05933187

A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants

The purpose of this trial is to evaluate plasma concentrations of emraclidine following single dose oral administration of different emraclidine immediate release (IR) tablets in healthy participants.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Overland Park, Kansas

Overland Park, Kansas, 66212, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Sexually active women of childbearing potential must agree to use at least an acceptable birth control method, during the trial and for 7 days after the last dose of investigational medicinal product (IMP)
  • Body mass index of 18.5 to 35.0 kilogram/meter square (kg/m^2), inclusive, and a total body weight ≥50 kg
  • Healthy as determined by medical evaluation, including medical and psychiatric history, physical and neurological examinations, ECG, vital sign measurements, and laboratory test results, as evaluated by the investigator
  • Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures

Exclusion criteria

  • Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial
  • "Yes" responses for any of the following items on the C-SSRS (within the individual's lifetime):
  • Suicidal Ideation Item 3 (Active Suicidal Ideation With Any Methods [Not Plan] Without Intent to Act)
  • Suicidal Ideation Item 4 (Active Suicidal Ideation With Some Intent to Act, Without Specific Plan)
  • Suicidal Ideation Item 5 (Active Suicidal Ideation With Specific Plan and Intent)
  • Any of the Suicidal Behavior items (Actual Attempt, Interrupted Attempt, Aborted Attempt, or Preparatory Acts/Behavior)
  • "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
  • Suicidal Ideation Item 1 (Wish to be Dead)
  • Suicidal Ideation Item 2 (Non-Specific Active Suicidal Thoughts) Serious risk of suicide in the opinion of the investigator is also exclusionary
  • Any condition or surgery that could possibly affect drug absorption, including, but not limited to, bowel resections, bariatric weight loss surgery/procedures, gastrectomy, and cholecystectomy
  • Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B total core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at screening
  • Positive drug screen (including cotinine and tetrahydrocannabinol (THC)) or a positive test for alcohol
  • Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP
  • Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients
  • Received IMP in a clinical trial of emraclidine

NOTE: Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Treatment A: Emraclidine 30mg IR tablets (reference)

Drug

IR oral tablets

Other names: CVL-231

Treatment B: Emraclidine 30mg IR test tablets 1

Drug

IR oral tablets

Other names: CVL-231

Treatment C: Emraclidine 30mg IR test tablets 2

Drug

IR oral tablets

Other names: CVL-231

Treatment D: Emraclidine 30mg IR test tablets 3

Drug

IR oral tablets

Other names: CVL-231

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Emraclidine

    Time frame: Predose and up to 96 hours post dose in each treatment period

  2. Time to Maximum Plasma Concentration (Tmax) of Emraclidine

    Time frame: Predose and up to 96 hours post dose in each treatment period

  3. Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine

    Time frame: Predose and up to 96 hours post dose in each treatment period

  4. Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine

    Time frame: Predose and up to 96 hours post dose in each treatment period

Secondary outcomes

  1. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to approximately 4 months

  2. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results

    Time frame: Up to approximately 4 months

  3. Number of Participants With Clinically Significant Changes in Vital Sign Values

    Time frame: Up to approximately 4 months

  4. Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments

    Time frame: Up to approximately 4 months

  5. Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results

    Time frame: Screening up to checkout (up to approximately 4 months)

  6. Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to approximately 4 months

    The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

Sponsors and collaborators

Lead sponsor

Cerevel Therapeutics, LLC

Industry

Registry information

Official study title

A Phase 1, Open-label Trial to Evaluate the Pharmacokinetics and Relative Bioavailability of Emraclidine Following a Single Oral Administration of Immediate-Release Tablets in Healthy Adult Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2023
Registry last updated
Nov 24, 2023

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.

Published trials that share one or more normalized conditions with this study.