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

• Status: Terminated
• Trial end date: 2020-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cerevel Therapeutics, LLC

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.