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

Cerevel Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Substance Use Disorders (SUD)

Treatments: Drug: Matching Placebo; Drug: CVL-936

Study type: Interventional

Funder types: Industry

Identifiers

NCT04232878

CVL-936-HV-001

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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10 participants in 14 patient groups, including a placebo group

Active Comparator: Group 1 Period 1: 0.5mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 1 Period 1: 0.5mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 1 Period 2:TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 1 Period 2:TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 1 Period 3:TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 1 Period 3:TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 2 Period 1:TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 2 Period 1:TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 2 Period 2:TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 2 Period 2:TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 2 Period 3:TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 2 Period 3:TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo

Active Comparator: Group 3: TBD mg CVL-936

Active Comparator group

Description:

Oral suspension/solution

Treatment:

Drug: CVL-936

Placebo Comparator: Group 3: TBD mg Matching Placebo

Placebo Comparator group

Description:

Matching Placebo; Oral suspension/solution

Treatment:

Drug: Matching Placebo