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

Cerevel Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05933187

CVL-231-HV-1013

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Sequence 1: A-B-C-D

Experimental group

Description:

Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence A-B-C-D orally, on Day 1 of each 5-day treatment period (up to 26 days)

Treatment:

Drug: Treatment B: Emraclidine 30mg IR test tablets 1

Drug: Treatment C: Emraclidine 30mg IR test tablets 2

Drug: Treatment A: Emraclidine 30mg IR tablets (reference)

Drug: Treatment D: Emraclidine 30mg IR test tablets 3

Sequence 2: B-C-D-A

Experimental group

Description:

Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence B-C-D-A orally, on Day 1 of each 5-day treatment period (up to 26 days)

Treatment:

Drug: Treatment B: Emraclidine 30mg IR test tablets 1

Drug: Treatment C: Emraclidine 30mg IR test tablets 2

Drug: Treatment A: Emraclidine 30mg IR tablets (reference)

Drug: Treatment D: Emraclidine 30mg IR test tablets 3

Sequence 3: C-D-A-B

Experimental group

Description:

Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence C-D-A-B orally, on Day 1 of each 5-day treatment period (up to 26 days)

Treatment:

Drug: Treatment B: Emraclidine 30mg IR test tablets 1

Drug: Treatment C: Emraclidine 30mg IR test tablets 2

Drug: Treatment A: Emraclidine 30mg IR tablets (reference)

Drug: Treatment D: Emraclidine 30mg IR test tablets 3

Sequence 4: D-A-B-C

Experimental group

Description:

Participants will receive emraclidine, 30 mg IR tablets, in the treatment sequence D-A-B-C orally, on Day 1 of each 5-day treatment period (up to 26 days)

Treatment:

Drug: Treatment B: Emraclidine 30mg IR test tablets 1

Drug: Treatment C: Emraclidine 30mg IR test tablets 2

Drug: Treatment A: Emraclidine 30mg IR tablets (reference)

Drug: Treatment D: Emraclidine 30mg IR test tablets 3