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SchizophreniaPhase 1NCT04787302

PET Trial to Evaluate Target Occupancy of CVL-231 on Brain Receptors Following Oral Dosing

A Phase 1 study testing CVL-231 in people with Schizophrenia, run by Cerevel Therapeutics, LLC at 2 sites in 2 countries.

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

PET Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Oral Dosing Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
CVL-231
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesin 2 countries
Study dates
1 Jun 2021to 14 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

  • Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 55 years, inclusive, at the time of signing the ICF
  • Sexually active men with a pregnant or a nonpregnant partner of childbearing potential must agree to use a double-barrier method of birth control, including a condom, and practice contraception during treatment and through 7 days post dose
  • Capable of providing informed consent and following study requirements

Who cannot join

  • Subjects who answer yes on the C-SSRS or, in the opinion of the investigator, present a serious risk of suicide
  • Subjects with a current history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, hematological, immunological, or neurological disease
  • Subjects with a 12-lead ECG demonstrating either of the following (average of 3 ECGs obtained at the Screening Visit):
  • QT interval corrected for heart rate using Fridericia's formula >450 msec
  • Left ventricular hypertrophy
  • Orthostatic hypotension, which is defined as a decrease of ≥20 mmHg in systolic blood pressure and/or a decrease of ≥10 mmHg in diastolic blood pressure after at least 3 minutes of standing compared with the immediately previous supine/semi-recumbent blood pressure at Screening or at the prescan time point prior to baseline PET scan.
Show all 15Show fewer
  • Subjects with a current or past personal history of any psychiatric disorder as classified by DSM-5 criteria or immediate family members with any psychiatric disorder as classified by DSM-5 criteria that require treatment
  • Subjects with a history of substance or alcohol-use disorder (DSM-5 criteria) within 2 years prior to signing the ICF
  • Subjects with other abnormal laboratory test results, vital sign results, or ECG findings
  • Subjects who currently use or have used tobacco or nicotine-containing products within 30 days prior to signing the ICF
  • Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure (5 rem per year)
  • Subjects with any anatomical abnormality in the head that would either preclude or tend to confound the analysis of study data, including any clinically significant abnormal findings from MRI of the head
  • Current, past or anticipated exposure to radiation in the workplace
  • Any subject with a significant acute illness within 7 days prior to administration of study drug or have had a major illness or hospitalization within 1 month prior to administration of study drug
  • Any subject who, in the opinion of the sponsor, investigator, or medical monitor, should not participate in the trial

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Massachusetts General Hospital Translational and Clinical Research Centers

    Boston, Massachusetts, 02114

Other trials in United States

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: A Phase 1, Open-label Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Single Oral Doses Using Positron Emission Tomography in Healthy Adult Subjects

PET Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Oral Dosing

Read the detailed description

CVL-231 is a muscarinic acetylcholine receptor (mAChR) activator that selectively binds to the M4 muscarinic receptor subtype (M4 mAChR). CVL-231 is being developed for treatment of psychosis in schizophrenia. The aim of this trial is to characterize the relationship between the M4 receptor occupancy in different regions of the brain following a single oral doses of CVL-231 in healthy adult subjects by positron emission tomography (PET) using the radioligand [11C]MK-6884.

Conditions
Schizophrenia
Being tested
CVL-231
Keywords
Schizophrenia, PET, Healthy Volunteer
Medical subject headings
Schizophrenia

What participants receive

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

  • CVL-231Drug

    Also called PF-06852231

    Cohort 1: 30mg dose of CVL-231

  • CVL-231Drug

    Also called PF-06852231

    Cohort 2: CVL-231 dose to be decided based on results of Cohort 1 or trial may be concluded

  • CVL-231Drug

    Also called PF-06852231

    Cohort 3: CVL-231 dose to be decided based on results of Cohorts 1 and/or 2

Study groups in NCT04787302
Study groupRoleWhat they receive
CVL-231ExperimentalNot described
Receives: Drug: CVL-231

What is being measured

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

  1. M4 receptor occupancy in the striatum following single oral doses of CVL-231 in healthy adult subjects

    Fraction of M4 receptors occupied by CVL-231 doses

    Measured: Day 1

Secondary outcomes (10)

  1. Treatment-emergent adverse events

    Measured: Upto 9 weeks

  2. Number of subjects with Clinically significant changes in Electrocardiogram

    Measured: Screening, Pre-scan, Day-1, Day 1 (T=0hour), Day 1 (T=0.5hour), Day 1 (T=3.0hour), Day 2 (T=24hour), Day 10

  3. Number of subjects with clinical significant Clinical laboratory assessments

    Measured: Screening, Pre-scan, Day-1, Day 2 (T=24hour)

  4. Number of subjects with Clinically significant changes in Vital signs

    Measured: Screening, Day-1 (T=1hour), Day-1 (T=1.5hour), Day-1, Day 1 (T=0hour), Day 1(T=1.5hour), Day 1 (T=3hour), Day 1 (T=6hr), Day 1 (T=8.0), Day 2 (T-=24hr), Day 10

  5. Number of subjects with clinically significant Physical and neurological examination results

    Measured: Screening, Day-1 pre-scan, Day-1, Day 2

  6. Suicidality assessed using the Columbia-Suicide Severity Rating Scale

    Suicidality will be monitored during the trial using the Columbia - Suicide Severity Rating Scale (C-SSRS)

    Measured: Screening, Day-1, Day 2, Day 10

  7. Cmax during scan for CVL-231

    Max CVL-231 concentration during PET scan

    Measured: Day 1 (0.5, 1.5 and 2.0 hours)

  8. AUCscan duration for CVL-231

    AUC for CVL-231 during PET scan

    Measured: Day 1 (0.5, 1.5 and 2.0 hours)

  9. Cavg/Scan duration for CVL-231

    Average CVL-231 concentration during scan

    Measured: Day 1 (0.5, 1.5 and 2.0 hours)

  10. Model estimated Emax and EC50 at M4 receptors in striatum for CVL-231

    Model estimated values for Maximum possible binding (Emax) and CVL-231 concentrations required from hal-maximal binding (EC50)

    Measured: Day 1

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 2021
  2. Study start1 Jun 2021
  3. Primary completion14 Jul 2023
  4. Study completion14 Jul 2023

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04787302
Sponsor's protocol ID
CVL-231-1002
Status last verified
Jul 2023
First submitted
1 Feb 2021
Last updated
27 Jul 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CVL-231 in people with Schizophrenia, run by Cerevel Therapeutics, LLC at 2 sites in 2 countries.

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 3 inclusion and 15 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 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Belgium. 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?

M4 receptor occupancy in the striatum following single oral doses of CVL-231 in healthy adult subjects (time frame: Day 1). 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 NCT04787302.

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 27 Jul 2023.

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