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CompletedNCT05933187Updated Nov 24, 2023

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

A Phase 1 interventional study of Treatment A: Emraclidine 30mg IR tablets (reference) and Treatment B: Emraclidine 30mg IR test tablets 1 in Healthy Participants, 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 (part of AbbVie) · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2023, 3 years 1 month ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Participants
03

In context

Lead sponsor

Cerevel Therapeutics, LLC is the lead sponsor of 22 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.

First submitted before Cerevel Therapeutics, LLC became part of AbbVie.

Browse Cerevel Therapeutics, LLC studies →All AbbVie studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

05

Study design

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

Study arms

  • Experimental
    Sequence 1: A-B-C-D

    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)

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

  • Experimental
    Sequence 2: B-C-D-A

    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)

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

  • Experimental
    Sequence 3: C-D-A-B

    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)

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

  • Experimental
    Sequence 4: D-A-B-C

    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)

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

Interventions

06

What researchers measure

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)

    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 approximately 4 months

07

Study locations

1 site
  • Overland Park, Kansas
    Overland Park, Kansas 66212, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2023 to primary completion in Sep 2023, 1 month.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2023
First posted
Jul 6, 2023
StartActual
Jul 19, 2023
Primary completionActual
Sep 12, 2023
CompletionActual
Sep 12, 2023
Last update
Nov 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
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
NCT05933187
Lead sponsor
Cerevel Therapeutics, LLC
Responsible party
Sponsor
First posted
Jul 6, 2023
Start date
Jul 19, 2023
Primary completion
Sep 12, 2023
Completion
Sep 12, 2023
Last update
Nov 24, 2023

Oversight

Data monitoring committee
No
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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