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

Healthy Participants Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05933187
• Other study ID #: CVL-231-HV-1013
• Status: Completed
• Phase: Phase 1
• Start date: July 19, 2023
• Est. completion date: September 12, 2023

Study information

• Verified date: November 2023
• Source: Cerevel Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Treatment A: Emraclidine 30mg IR tablets (reference)
IR oral tablets
• Treatment B: Emraclidine 30mg IR test tablets 1
IR oral tablets
• Treatment C: Emraclidine 30mg IR test tablets 2
IR oral tablets
• Treatment D: Emraclidine 30mg IR test tablets 3
IR oral tablets

Locations

Country	Name	City	State
United States	Overland Park, Kansas	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax) of Emraclidine		Predose and up to 96 hours post dose in each treatment period
Primary	Time to Maximum Plasma Concentration (Tmax) of Emraclidine		Predose and up to 96 hours post dose in each treatment period
Primary	Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine		Predose and up to 96 hours post dose in each treatment period
Primary	Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine		Predose and up to 96 hours post dose in each treatment period
Secondary	Number of Participants with Treatment Emergent Adverse Events (TEAEs)		Up to approximately 4 months
Secondary	Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results		Up to approximately 4 months
Secondary	Number of Participants With Clinically Significant Changes in Vital Sign Values		Up to approximately 4 months
Secondary	Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments		Up to approximately 4 months
Secondary	Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results		Screening up to checkout (up to approximately 4 months)
Secondary	Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)	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.	Up to approximately 4 months