Clinical trial NCT04232878: A Single Ascending Dose Trial of CVL-936 in Healthy Subjects
Official title: A Phase 1, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Trial To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Ascending Doses of CVL-936 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Substance Use Disorders (SUD)
Lead sponsor: Cerevel Therapeutics, LLC
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A sample size of 9 subjects per cohort has been chosen based on the need to minimize exposure of humans to CVL-936 and PF-06815106 and the requirement to provide adequate safety, tolerability, and PK information at each dose. Each cohort will be conducted as a crossover design with 3 periods and each cohort will have up to 6 subjects receiving CVL-936 and 3 subjects receiving placebo within each period, with a total of approximately 18 subjects if 2 cohorts complete or a total of approximately 27 subjects if 3 cohorts complete.
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-936 following single ascending oral doses in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years

Exclusion Criteria:

1. Subjects with a current history of significant pulmonary, gastrointestinal, renal, hepatic, metabolic, endocrine, hematological, immunological, psychiatric, or neurological disease that, in the opinion of the investigator or medical monitor, could compromise either subject safety or the results of the trial.
2. Subjects with epilepsy or a history of seizures
3. Systolic supine blood pressure ≥130 mmHg and/or supine diastolic blood pressure ≥80 mmHg at Screening or Day -1, or orthostatic hypotension at Screening or Day -1.
4. Subjects with a history of hypersensitivity to any dopamine-blocker medication.

Primary outcomes:
measure: Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)
timeFrame: At the end of Period 3 (30 Days)
measure: Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF)
timeFrame: At the end of Period 3 (30 Days)
measure: Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)
timeFrame: At the end of Period 3 (30 Days)
measure: Number of Subjects with Clinically significant changes in laboratory measures
timeFrame: At the end of Period 3 (30 Days)
measure: Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: At the end of Period 3 (30 Days)
measure: Change from Baseline of Simpson-Angus Scale (SAS) Results
timeFrame: At the end of Period 3 (30 Days)
measure: Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results
timeFrame: At the end of Period 3 (30 Days)
measure: Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results
timeFrame: At the end of Period 3 (30 Days)
Secondary outcomes:
Other outcomes:
Locations:
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
Study officials:
affiliation: Cerevel Therapeutics, LLC
name: Matt Leoni, MD
role: STUDY_DIRECTOR
References: