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CompletedNCT05915546Updated Nov 24, 2023

The Effect of Food on the Pharmacokinetics (PK) of Emraclidine in Healthy Adult Participants

A Phase 1 interventional study of Emraclidine in Healthy, sponsored by Cerevel Therapeutics, LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-24.

Sponsored by Cerevel Therapeutics, LLC · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jul 2023, 3 years 2 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the effect of food (a high-fat meal) on the pharmacokinetics of emraclidine and metabolite CV-0000364 following single oral dose administration in healthy adult participants.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Cerevel Therapeutics, LLC is the lead sponsor of 20 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male and female (both women of childbearing and nonchildbearing potential) participants, ages 18 to 55 years, at the time of signing the informed consent form (ICF).
  2. Sexually active women of childbearing potential must agree to use an acceptable birth control method, during the trial and for 7 days after the last dose. Acceptable birth control methods that result in a failure rate of more than 1% per year include the following:

    • Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
    • Male or female condom with or without spermicide
    • Cap, diaphragm, or sponge with spermicide
  3. Body mass index of 17.5 to 32.0 kilograms per square meter (kg/m\^2), inclusive, and total body weight >45 kg (110 pounds [lb]) at Screening.
  4. 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.
  5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the full protocol.
  6. 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

Exclusion Criteria:

  1. 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.
  2. "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
  3. 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.
  4. Use of any prescription and over-the-counter medications from 28 days prior to first dose of Investigational Medical Product or likely to require concomitant therapy (e.g., prescription and over-the counter medications, herbal medications, vitamins, and supplements) during the trial, with the exception of acetaminophen (maximum total daily dose of 2 g) and topical hydrocortisone as needed for treatment of an Adverse Event(AE). Vaccinations or boosters within 7 days of planned dosing or while on trial are prohibited.
  5. Positive result for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C antibody with detectable viral ribonucleic acid (RNA) levels at Screening.
  6. Positive drug screen or a positive test for alcohol at Screening or Baseline Visits.
  7. Female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit and a negative urine pregnancy test result at baseline.
  8. Any of the following clinical laboratory test results at the Screening Visit (as assessed by the central laboratory) and at Check-in (Day -1; as assessed by the local laboratory), and confirmed by a single repeat measurement, if deemed necessary:

    • aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.0 × upper limit normal (ULN)
    • Total bilirubin >1.5 × ULN. If Gilbert's syndrome is suspected, total bilirubin >1.5 × ULN is acceptable if the conjugated or direct bilirubin fraction is \<20% of total bilirubin.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    Emraclidine (Fasted then Fed)

    Single oral dose of Emraclidine 15 mg tablet under fasted (without food) condition followed by fed condition in treatment period 1 and 2, respectively.

    Drug: Emraclidine

  • Experimental
    Emraclidine (Fed then Fasted)

    Single oral dose of Emraclidine 15 mg tablet under fed condition followed by fasted (without food) condition in treatment period 1 and 2, respectively.

    Drug: Emraclidine

Interventions

  • DrugEmraclidine

    Tablets

06

What researchers measure

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364

    Time frame: Pre-dose and at multiple timepoints up to Day 6

  2. Time to Maximum Plasma Concentration (Tmax) of Emraclidine and its Metabolite CV-0000364

    Time frame: Pre-dose and at multiple timepoints up to Day 6

  3. Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364

    Time frame: Pre-dose and at multiple timepoints up to Day 6

  4. Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364

    Time frame: Pre-dose and at multiple timepoints up to Day 6

Secondary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to Day 13

  2. Number of Participants With Clinically Significant Changes in Vital Sign Measurements

    Time frame: Up to Day 13

  3. Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Up to Day 13

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

    Time frame: Up to Day 13

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

    Time frame: Up to Day 13

  6. Changes in Suicidality Assessed Using 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.

    Time frame: Up to Day 13

07

Study locations

1 site
  • Dilworth, Minnesota
    Dilworth, Minnesota 56529, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05915546
Lead sponsor
Cerevel Therapeutics, LLC
Responsible party
Sponsor
First posted
Jun 23, 2023
Start date
Jun 8, 2023
Primary completion
Jul 26, 2023
Completion
Jul 26, 2023
Last update
Nov 24, 2023

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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