Clinical trial NCT05933187: A Study Evaluating the Pharmacokinetics and Relative Bioavailability of Emraclidine Immediate-Release Tablets in Healthy Adult Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Cerevel Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2023-07-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 4-period, 4-sequence crossover study. The 4 treatments are A- 30 milligrams (mg) emraclidine IR tablets (reference); B- 30 mg emraclidine IR test tablets 1; C- 30 mg emraclidine IR test tablets 2; D- 30 mg emraclidine IR test tablets 3. Participants will be randomized to 1 of 4 treatment sequences. Each participant will be administered each of the 4 treatments exactly once, i.e.,1 treatment per period and there will be a 7 day washout period between each treatment.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Emraclidine
timeFrame: Predose and up to 96 hours post dose in each treatment period
measure: Time to Maximum Plasma Concentration (Tmax) of Emraclidine
timeFrame: Predose and up to 96 hours post dose in each treatment period
measure: Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
timeFrame: Predose and up to 96 hours post dose in each treatment period
measure: Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
timeFrame: Predose and up to 96 hours post dose in each treatment period
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 4 months
measure: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
timeFrame: Up to approximately 4 months
measure: Number of Participants With Clinically Significant Changes in Vital Sign Values
timeFrame: Up to approximately 4 months
measure: Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
timeFrame: Up to approximately 4 months
measure: Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
timeFrame: Screening up to checkout (up to approximately 4 months)
measure: Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to approximately 4 months
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Overland Park, Kansas
state: Kansas
Study officials:
References: