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

NCT04787302 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-231-1002
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; PET; Healthy Volunteer

Outcome Measures

Primary Outcomes (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

  Day 1

Secondary Outcomes (10)

• Treatment-emergent adverse events

  Upto 9 weeks

• Number of subjects with Clinically significant changes in Electrocardiogram

  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

• Number of subjects with clinical significant Clinical laboratory assessments

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

• Number of subjects with Clinically significant changes in Vital signs

  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

• Number of subjects with clinically significant Physical and neurological examination results

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

Study Arms (1)

CVL-231

EXPERIMENTAL

Drug: CVL-231

Interventions

CVL-231 DRUG

Cohort 1: 30mg dose of CVL-231

Also known as: PF-06852231

CVL-231

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (2)

Massachusetts General Hospital Translational and Clinical Research Centers

Boston, Massachusetts, 02114, United States

Location

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Matthew Leoni, MD, MBA

  Cerevel Therapeutics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 8, 2021
• Study Start: June 1, 2021
• Primary Completion: July 14, 2023
• Study Completion: July 14, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

BE (1); US (1)