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

Study Identifier
CVL-936-HV-001
CT.gov Identifier
NCT04232878
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Details

Medical Condition
  • Other
    • Study Drug
  • CVL-936
  • Matching Placebo
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18 - 50 Years
    Inclusion and Exclusion 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    Hassman Research Institute
    Marlton, New Jersey, United States, 08053
    Status
    Not applicable