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A Single Ascending Dose Trial of CVL-936 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232878
Recruitment Status : Terminated (Sufficient data has been obtained to meet current objectives)
First Posted : January 18, 2020
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cerevel Therapeutics, LLC

Tracking Information
First Submitted Date  ICMJE January 10, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE December 16, 2019
Actual Primary Completion Date March 6, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs) [ Time Frame: At the end of Period 3 (30 Days) ]
  • Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF) [ Time Frame: At the end of Period 3 (30 Days) ]
  • Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature) [ Time Frame: At the end of Period 3 (30 Days) ]
  • Number of Subjects with Clinically significant changes in laboratory measures [ Time Frame: At the end of Period 3 (30 Days) ]
    Number of subjects with clinically significant changes in hematology, serum chemistry and urinalysis will be reported
  • Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: At the end of Period 3 (30 Days) ]
    The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
  • Change from Baseline of Simpson-Angus Scale (SAS) Results [ Time Frame: At the end of Period 3 (30 Days) ]
    Evaluating Extrapyramidal symptoms using the SAS. The SAS consists of a list of 10 symptoms of parkinsonism (gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, head rotation, glabella tap, tremor, salivation, and akathisia). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
  • Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results [ Time Frame: At the end of Period 3 (30 Days) ]
    The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1 through 4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the subject is at rest, and the investigator also makes global judgments on the subject's dyskinesias (items 8 through 10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status. The AIMS Movement Rating Score is defined as the sum of items 1 through 7 (ie, items 1 through 4, facial and oral movements; items 5 and 6, extremity movements; and item 7, trunk movements).
  • Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results [ Time Frame: At the end of Period 3 (30 Days) ]
    Evaluating Extrapyramidal symptoms using the BARS. The BARS consists of 4 items related to akathisia: objective observation of akathisia by the investigator, subjective feelings of restlessness by the subject, subjective distress due to akathisia, and global clinical assessment of akathisia. The first 3 items are rated on a 4‑point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Single Ascending Dose Trial of CVL-936 in Healthy Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders (SUD)
Intervention  ICMJE
  • Drug: CVL-936
    CVL-936
  • Drug: Matching Placebo
    Placebo matching CVL-936
Study Arms  ICMJE
  • Active Comparator: Active Comparator: Group 1 Period 1: 0.5mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 1 Period 2:TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 1 Period 3:TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 2 Period 1:TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 2 Period 2:TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 2 Period 3:TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
  • Active Comparator: Active Comparator: Group 3: TBD mg CVL-936
    Oral suspension/solution
    Intervention: Drug: CVL-936
  • Placebo Comparator: Placebo Comparator: Group 3: TBD mg Matching Placebo
    Matching Placebo; Oral suspension/solution
    Intervention: Drug: Matching Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 18, 2020)
10
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2020)
27
Actual Study Completion Date  ICMJE May 21, 2020
Actual Primary Completion Date March 6, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04232878
Other Study ID Numbers  ICMJE CVL-936-HV-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Cerevel Therapeutics, LLC
Study Sponsor  ICMJE Cerevel Therapeutics, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matt Leoni, MD Cerevel Therapeutics, LLC
PRS Account Cerevel Therapeutics, LLC
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP