Healthy ParticipantsPhase 1NCT05933187

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

A Phase 1 study testing Treatment A: Emraclidine 30mg IR tablets (reference), Treatment B: Emraclidine 30mg IR test tablets 1 and Treatment C: Emraclidine 30mg IR test tablets 2 in people with Healthy Participants, run by Cerevel Therapeutics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Treatment A: Emraclidine 30mg IR tablets (reference), Treatment B: Emraclidine 30mg IR test tablets 1 and Treatment C: Emraclidine 30mg IR test tablets 2
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 19 Jul 2023to 12 Sep 2023
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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)

Show all 16Show fewer

"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 locations and contacts

1 site in 1 country.

United States1 site

Overland Park, Kansas
Overland Park, Kansas, 66212

Other trials in United States

About this study

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

Conditions: Healthy Participants
Being tested: Treatment A: Emraclidine 30mg IR tablets (reference), Treatment B: Emraclidine 30mg IR test tablets 1, Treatment C: Emraclidine 30mg IR test tablets 2, Treatment D: Emraclidine 30mg IR test tablets 3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A: Emraclidine 30mg IR tablets (reference)Drug
Also called CVL-231
IR oral tablets
Treatment B: Emraclidine 30mg IR test tablets 1Drug
Also called CVL-231
IR oral tablets
Treatment C: Emraclidine 30mg IR test tablets 2Drug
Also called CVL-231
IR oral tablets
Treatment D: Emraclidine 30mg IR test tablets 3Drug
Also called CVL-231
IR oral tablets

Study groups in NCT05933187
Study group	Role	What they receive
Sequence 1: A-B-C-D	Experimental	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) Receives: 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
Sequence 2: B-C-D-A	Experimental	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) Receives: 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
Sequence 3: C-D-A-B	Experimental	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) Receives: 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
Sequence 4: D-A-B-C	Experimental	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) Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Measured: Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Measured: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 to the time of Last Quantifiable Concentration (AUC0-t) of Emraclidine
Measured: Predose and up to 96 hours post dose in each treatment period
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUCinf) of Emraclidine
Measured: Predose and up to 96 hours post dose in each treatment period

Secondary outcomes (6)

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately 4 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Measured: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Vital Sign Values
Measured: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Measured: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Measured: Screening up to checkout (up to approximately 4 months)
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.
Measured: Up to approximately 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jul 202312 Sep 2023

First posted6 Jul 2023
Study start19 Jul 2023
Primary completion12 Sep 2023
Study completion12 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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.
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05933187
Sponsor's protocol ID: CVL-231-HV-1013
Status last verified: Nov 2023
First submitted: 28 Jun 2023
Last updated: 24 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05933187
Acronym / sponsor ID: CVL-231-HV-1013
Conditions: Healthy Participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
Study start: 19 Jul 2023 (actual)
Primary completion: 12 Sep 2023 (actual)
Study completion: 12 Sep 2023 (actual)
First posted: 6 Jul 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
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.

Arm	Type	Receives
Sequence 1: A-B-C-D	Experimental	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 3Participants 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)
Sequence 2: B-C-D-A	Experimental	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 3Participants 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)
Sequence 3: C-D-A-B	Experimental	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 3Participants 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)
Sequence 4: D-A-B-C	Experimental	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 3Participants 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)

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (16 listed)

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):
"Yes" responses for any of the following items on the C-SSRS (within past 12 months):
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment A: Emraclidine 30mg IR tablets (reference)Also: CVL-231IR oral tablets	Drug	Sequence 1: A-B-C-D, Sequence 2: B-C-D-A, Sequence 3: C-D-A-B, Sequence 4: D-A-B-C
Treatment B: Emraclidine 30mg IR test tablets 1Also: CVL-231IR oral tablets	Drug	Sequence 1: A-B-C-D, Sequence 2: B-C-D-A, Sequence 3: C-D-A-B, Sequence 4: D-A-B-C
Treatment C: Emraclidine 30mg IR test tablets 2Also: CVL-231IR oral tablets	Drug	Sequence 1: A-B-C-D, Sequence 2: B-C-D-A, Sequence 3: C-D-A-B, Sequence 4: D-A-B-C
Treatment D: Emraclidine 30mg IR test tablets 3Also: CVL-231IR oral tablets	Drug	Sequence 1: A-B-C-D, Sequence 2: B-C-D-A, Sequence 3: C-D-A-B, Sequence 4: D-A-B-C

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Emraclidine
Time frame: Predose and up to 96 hours post dose in each treatment period
Time to Maximum Plasma Concentration (Tmax) of Emraclidine
Time frame: Predose and up to 96 hours post dose in each treatment period
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
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

6 secondary outcomes

Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 4 months
Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Time frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Vital Sign Values
Time frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Clinical Laboratory Assessments
Time frame: Up to approximately 4 months
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Screening up to checkout (up to approximately 4 months)
Changes in Suicidality as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to approximately 4 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Emraclidine (time frame: Predose and up to 96 hours post dose in each treatment period). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05933187.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.