HealthyPhase 1NCT05915546
The Effect of Food on the Pharmacokinetics (PK) of Emraclidine in Healthy Adult Participants
A Phase 1 study testing Emraclidine in people with Healthy, run by Cerevel Therapeutics, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2023to 26 Jul 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
- 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).
- 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
- 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.
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- 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.
- 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.
- 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) "Yes" responses for any of the following items on the C-SSRS (within past 12 months):
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- 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 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.
- 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.
- Positive drug screen or a positive test for alcohol at Screening or Baseline Visits.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Trial to Evaluate the Effect of Food on the Pharmacokinetics of Emraclidine in Healthy Adult Participants
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.
- Conditions
- Healthy
- Being tested
- Emraclidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmraclidineDrug
Tablets
| Study group | Role | What they receive |
|---|---|---|
| Emraclidine (Fasted then Fed) | Experimental | Single oral dose of Emraclidine 15 mg tablet under fasted (without food) condition followed by fed condition in treatment period 1 and 2, respectively. Receives: Drug: Emraclidine |
| Emraclidine (Fed then Fasted) | Experimental | Single oral dose of Emraclidine 15 mg tablet under fed condition followed by fasted (without food) condition in treatment period 1 and 2, respectively. Receives: Drug: Emraclidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple timepoints up to Day 6
Time to Maximum Plasma Concentration (Tmax) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple timepoints up to Day 6
Area Under the Plasma Concentration-time Curve from Time Zero to Last Specified Sampling Time (AUC0-t) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple timepoints up to Day 6
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Emraclidine and its Metabolite CV-0000364
Measured: Pre-dose and at multiple timepoints up to Day 6
Secondary outcomes (6)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Day 13
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Measured: Up to Day 13
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Measured: Up to Day 13
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Measured: Up to Day 13
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Measured: Up to Day 13
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.
Measured: Up to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start8 Jun 2023
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915546
- Sponsor's protocol ID
- CVL-231-HV-1009
- Status last verified
- Nov 2023
- First submitted
- 13 Jun 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 Effect of Food on the Pharmacokinetics of Emraclidine in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05915546
- Acronym / sponsor ID
- CVL-231-HV-1009
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 23 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Emraclidine (Fasted then Fed) | Experimental | Drug: EmraclidineSingle oral dose of Emraclidine 15 mg tablet under fasted (without food) condition followed by fed condition in treatment period 1 and 2, respectively. |
| Emraclidine (Fed then Fasted) | Experimental | Drug: EmraclidineSingle oral dose of Emraclidine 15 mg tablet under fed condition followed by fasted (without food) condition in treatment period 1 and 2, respectively. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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).
- 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:
- 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.
- 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.
- 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.
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):
- 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 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.
- 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.
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 |
|---|---|---|
| EmraclidineTablets | Drug | Emraclidine (Fasted then Fed), Emraclidine (Fed then Fasted) |
Primary outcome
Maximum Observed Plasma Concentration (Cmax) of Emraclidine and its Metabolite CV-0000364
Time frame: Pre-dose and at multiple timepoints up to Day 6
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
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
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
6 secondary outcomes
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Vital Sign Measurements
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Laboratory Assessments
Time frame: Up to Day 13
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Time frame: Up to Day 13
Changes in Suicidality Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 13
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?
A Phase 1 study testing Emraclidine in people with Healthy, 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 9 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 and its Metabolite CV-0000364 (time frame: Pre-dose and at multiple timepoints up to Day 6). 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?
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.