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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Substance Use Disorders (SUD)

In brief

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.

Key facts

Study ID

NCT04232878

Run by

Cerevel Therapeutics, LLC

People needed

10

Starts

2019-12-16

Expected to finish

2020-05-21

Last updated by the study team

2020-06-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male subjects and female subjects of nonchildbearing potential, ages 18 to 50 years

You may not qualify if…

• 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.
• Subjects with epilepsy or a history of seizures
• 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.
• Subjects with a history of hypersensitivity to any dopamine-blocker medication.

Where it is running

• Hassman Research Institute — Marlton, New Jersey, United States

Full record on ClinicalTrials.gov

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