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

Substance Use Disorders (SUD) Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04232878
• Other study ID #: CVL-936-HV-001
• Status: Terminated
• Phase: Phase 1
• Start date: December 16, 2019
• Est. completion date: May 21, 2020

Study information

• Verified date: June 2020
• Source: Cerevel Therapeutics, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 21, 2020
• Est. primary completion date: March 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use Disorders (SUD)
• Substance-Related Disorders

Intervention

Drug:
• CVL-936
CVL-936
• Matching Placebo
Placebo matching CVL-936

Locations

Country	Name	City	State
United States	Hassman Research Institute	Marlton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Cerevel Therapeutics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with reported Treatment Emergent Adverse Events (TEAEs)		At the end of Period 3 (30 Days)
Primary	Number of Subjects with Clinically significant changes in Electrocardiogram measures (PR, RR, QT and QTcF)		At the end of Period 3 (30 Days)
Primary	Number of Subjects with Clinically meaningful changes in Vital signs (Systolic and Diastolic blood pressures, heart rate, respiratory rate and body temperature)		At the end of Period 3 (30 Days)
Primary	Number of Subjects with Clinically significant changes in laboratory measures	Number of subjects with clinically significant changes in hematology, serum chemistry and urinalysis will be reported	At the end of Period 3 (30 Days)
Primary	Change from baseline of the Columbia-Suicide Severity Rating Scale (C-SSRS)	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).	At the end of Period 3 (30 Days)
Primary	Change from Baseline of Simpson-Angus Scale (SAS) Results	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.	At the end of Period 3 (30 Days)
Primary	Change from Baseline of Abnormal Involuntary Movement Scale (AIMS) Results	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).	At the end of Period 3 (30 Days)
Primary	Change from Baseline of Barnes Akathisia Rating Scale (BARS) Results	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.	At the end of Period 3 (30 Days)