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Healthy ParticipantsPhase 1NCT06301971

A Study to Assess Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

A Phase 1 study testing Emraclidine 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 primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of [14C]-emraclidine in healthy… Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Emraclidine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
4 Mar 2024to 4 Apr 2024
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body mass index (BMI) of 18.5 to 35.0 kilograms per square meters (kg/m^2), inclusive, and a total body weight ≥50 kg [110 Pounds (lbs)].
  • A male participant who is sexually active with a pregnant or a nonpregnant woman of childbearing potential must agree to use a condom during the trial and for 90 days after the dose of investigational medicinal product (IMP). In addition, male participants should not donate sperm for a minimum of 90 days following the dose of IMP.
  • 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.
  • Capable of consuming the standard diet.
  • History of a minimum of 1 bowel movement per day.

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, Preparatory Acts or Behavior)
Show all 18Show 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.
  • Use of any prescription and over-the-counter medications from 28 days prior to first dose of IMP or likely to require concomitant therapy. Vaccinations or boosters within 28 days of planned dosing or while on trial.
  • 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.
  • Any of the following clinical laboratory test results at the Screening Visit or Check-in (Day -1), which can be confirmed by a single repeat measurement, if deemed necessary:
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2× upper limit of 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.
  • Known allergy or hypersensitivity to the IMP, closely related compounds, or any of their specified ingredients.
  • NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Austin, Texas

    Austin, Texas, 78744

Other trials in United States

About this study

Official title: A Phase 1, Open-Label Trial to Assess the Mass Balance, Pharmacokinetics, Metabolism, and Excretion of Emraclidine in Healthy Adult Male Participants

The primary purpose of this study is to determine the mass balance, routes, and rates of elimination of total radioactivity and characterize the pharmacokinetics (PK) of emraclidine, metabolite CV-0000364, and total radioactivity in plasma and whole blood following a single oral dose of [14C]-emraclidine in healthy adult male participants.

Being tested
Emraclidine

What participants receive

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

  • EmraclidineDrug

    Also called CVL-231

    Oral solution/suspension

Study groups in NCT06301971
Study groupRoleWhat they receive
Emraclidine 30 mgExperimentalParticipants will receive a single oral dose of 30 milligrams (mg) (approximately 75 microcurie [μCi]) [14C]-emraclidine on Day 1.
Receives: Drug: Emraclidine

What is being measured

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

  1. Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  2. AUC from Time 0 to last Quantifiable Concentration (AUClast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  3. Maximum Plasma Concentration (Cmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  4. Time to Last Measurable Concentration (Tlast) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  5. Time to Maximum Observed Concentration (Tmax) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  6. Apparent Terminal Elimination Half-life (t½) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  7. Terminal Rate Constant (λz) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  8. Total Plasma Clearance After Oral Administration (CL/F) of Emraclidine

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  9. Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Emraclidine

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  10. Ratio of Plasma AUCinf for Emraclidine to Plasma AUCinf for Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  11. Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  12. Ratio of Plasma AUCinf for Metabolite CV-0000364 to Plasma AUCinf for Emraclidine

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  13. Ratio of Whole Blood AUCinf for Total Radioactivity to Plasma AUCinf for Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  14. Amount Excreted in Urine (Aeu) of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  15. Cumulative Aeu of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  16. Percentage Excreted in Urine (feu) of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  17. Cumulative feu of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  18. Amount Excreted in Feces (Aef) of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  19. Cumulative Aef of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  20. Percentage Excreted in Feces (fef) of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  21. Cumulative fef of Total Radioactivity

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  22. Percentage Dose (%Dose) of Total Radioactivity Excreted in Urine Plus Feces Combined

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  23. Cumulative Percentage Dose of Total Radioactivity Excreted in Urine Plus Feces Combined

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

Secondary outcomes (8)

  1. Metabolite Profile of Emraclidine in Plasma, Urine and Feces

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  2. Structural Identification of Emraclidine Metabolites Found in Plasma, Urine and Feces

    Measured: Pre-dose and at multiple time points post-dose up to Day 15

  3. Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Measured: Up to Day 16

  4. Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Values

    Measured: Up to Day 15

  5. Number of Participants with Clinically Significant Changes in Vital Signs

    Measured: Up to Day 15

  6. Number of Participants with Clinically Significant Changes in Laboratory Assessments

    Measured: Up to Day 15

  7. Number of Participants with Clinically Significant Changes in Physical and Neurological Examination Results

    Measured: Up to Day 15

  8. Change from Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score

    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 Day 15

Timeline

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

  1. First posted8 Mar 2024
  2. Study start4 Mar 2024
  3. Primary completion4 Apr 2024
  4. Study completion4 Apr 2024

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06301971
Sponsor's protocol ID
CVL-231-HV-1011
Status last verified
May 2024
First submitted
1 Mar 2024
Last updated
2 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Emraclidine in people with Healthy Participants, run by Cerevel Therapeutics, LLC at 1 site in United States.

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 5 inclusion and 18 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 2 May 2024. 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?

Area Under the Concentration Time Curve (AUC) from Zero to Infinity (AUCinf) of Emraclidine, its Metabolite CV-0000364 and Total Radioactivity in Plasma and Whole Blood (time frame: Pre-dose and at multiple time points post-dose up to Day 15). The study lists 23 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 NCT06301971.

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 2 May 2024.

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