Summary:
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CVL-231 following multiple-dose oral administration in subjects with schizophrenia.
Inclusion Criteria:
Subjects are eligible to be included in the trial only if all of the following criteria apply:
- Male and female subjects, ages 18 to 50 years, inclusive, at the time of signing the Informed Consent Form (ICF).
- Subjects with a primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI.
- Subjects with the following scores on the PANSS at the time of signing the ICF and at Baseline (Day 1): • Positive Subscale 7 (hostility) ≤3 (normal to moderate) • General Psychopathology Subscale 8 (uncooperativeness) ≤3 (normal to moderate)
- Subjects with the following scores (normal to mild symptoms) at the time of signing the ICF and at Baseline (Day 1): • All individual items of the Modified SAS (M-SAS) <2 • All individual items (Items 1-7) of the Abnormal Involuntary Movement Scale (AIMS) <2 • Clinical global assessment item of the Barnes Akathisia Rating Scale (BARS) <3
- Subjects willing to discontinue all prohibited psychotropic medications to meet protocol required washouts prior to and during the trial period.
- Body mass index of 17.5 to 38.0 kg/m2 and a total body weight >50 kg (110 lbs).
- Sexually active men or women of childbearing potential must agree to practice effective birth control or remain abstinent during the trial and for 30 days after the last dose of IMP.
- Capable of giving signed informed consent), which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Ability, in the opinion of the investigator, to understand the nature of the trial and comply with protocol requirements, including the prescribed dosage regimens, scheduled visits, laboratory tests, and other trial procedures.
Qualified Participants May Receive:
Monetary compensation and study-related care at no cost to the participant