Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders (SUD) Drug: CVL-936 Drug: Matching Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
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
Actual Study Start Date : December 16, 2019
Actual Primary Completion Date : March 6, 2020
Actual Study Completion Date : May 21, 2020

Arm Intervention/treatment
Active Comparator: Active Comparator: Group 1 Period 1: 0.5mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 1 Period 2:TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 1 Period 3:TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 2 Period 1:TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 2 Period 2:TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 2 Period 3:TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936

Active Comparator: Active Comparator: Group 3: TBD mg CVL-936
Oral suspension/solution
Drug: CVL-936
CVL-936

Placebo Comparator: Placebo Comparator: Group 3: TBD mg Matching Placebo
Matching Placebo; Oral suspension/solution
Drug: Matching Placebo
Placebo matching CVL-936




Primary Outcome Measures :
  1. Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs) [ Time Frame: At the end of Period 3 (30 Days) ]
  2. 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) ]
  3. 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) ]
  4. 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

  5. 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).

  6. 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.

  7. 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).

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232878


Locations
Layout table for location information
United States, New Jersey
Hassman Research Institute
Marlton, New Jersey, United States, 08053
Sponsors and Collaborators
Cerevel Therapeutics, LLC
Investigators
Layout table for investigator information
Study Director: Matt Leoni, MD Cerevel Therapeutics, LLC
Layout table for additonal information
Responsible Party: Cerevel Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT04232878    
Other Study ID Numbers: CVL-936-HV-001
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders