Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Japanese Male and Female Subjects With Schizophrenia

Exclusion Criteria

• •1. Subjects who experienced an acute exacerbation of psychosis requiring change in antipsychotic medication (with reference to drug or dose) within 90 days before screening.
• •2. Subjects who become strongly affected by potent central nervous system depressants (including barbiturate) as considered by the Investigator.
• •3. Subjects who have any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study.
• •4. Subjects with active suicidal ideation or those with a suicide attempt history.
• •5. Subjects with a history or complication(s) of hypersensitivity to any medication.
• •6. Subjects with a history or complication(s) of malignant tumor within 5 years before screening, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. Pituitary tumors of any duration are excluded.
• •7. Subjects who have previous or existing infection with human immunodeficiency virus (HIV) at screening.
• •8. Subjects who have a positive syphilis serological test, Hepatitis B virus surface (HBs) antigen or Hepatitis C virus (HCV) antibody at screening.
• •other