Schizophrenia Clinical Trial
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
Verified date | July 2023 |
Source | Cerevel Therapeutics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
PET Trial to Evaluate Target Occupancy of CVL-231 at Muscarinic Receptors Type 4 in Brain Following Oral Dosing
Status | Completed |
Enrollment | 15 |
Est. completion date | July 14, 2023 |
Est. primary completion date | July 14, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven | |
United States | Massachusetts General Hospital Translational and Clinical Research Centers | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Cerevel Therapeutics, LLC |
United States, Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Treatment-emergent adverse events | Upto 9 weeks | ||
Secondary | 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 | ||
Secondary | Number of subjects with clinical significant Clinical laboratory assessments | Screening, Pre-scan, Day-1, Day 2 (T=24hour) | ||
Secondary | 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 | ||
Secondary | Number of subjects with clinically significant Physical and neurological examination results | Screening, Day-1 pre-scan, Day-1, Day 2 | ||
Secondary | 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) | Screening, Day-1, Day 2, Day 10 | |
Secondary | Cmax during scan for CVL-231 | Max CVL-231 concentration during PET scan | Day 1 (0.5, 1.5 and 2.0 hours) | |
Secondary | AUCscan duration for CVL-231 | AUC for CVL-231 during PET scan | Day 1 (0.5, 1.5 and 2.0 hours) | |
Secondary | Cavg/Scan duration for CVL-231 | Average CVL-231 concentration during scan | Day 1 (0.5, 1.5 and 2.0 hours) | |
Secondary | 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) | Day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |