A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Co-Administration of Roluperidone and Olanzapine in Adult Subjects With Moderate to Severe Negative Symptoms of Schizophrenia

Inclusion Criteria

• •Provided informed consent
• •Body mass index (BMI) \< 35 kg/m2
• •Meets the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5), as established by a full psychiatric interview in conjunction with the Mini International Neuropsychiatric Interview (MINI)
• •Documented diagnosis of schizophrenia for at least 1 year before screening
• •Stable in terms of both positive and negative symptoms of schizophrenia over the last 3 months
• •Score of \> 20 on the PANSS original negative symptoms subscale (Sum of N1+N2+N3+N4+N5+N6+N7) at Screening and Baseline (Day -1) AND \< 4 points absolute difference between the 2 visits
• •Discontinued psychotropic medications without risk to their clinical status or safety by Baseline
• •Female subject, if not of childbearing potential, must be a woman who is post-menopausal or permanently sterilized
• •Female subject, if of childbearing potential, must test negative for pregnancy and must be using a double barrier contraceptive method
• •Must be normal metabolizer for P450 CYP 2D6, defined as a subject that has at least one functional allele (eg, \*1, \*2 or \*35), as determined by study-specific genotyping test before the first drug dose is administered
• •Has a caregiver or family member or health care personnel who can provide information towards assessment and support the subject in terms of compliance with the protocol