A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules

Inclusion Criteria: Eligibility for this study was met if each one of the following inclusion criteria was satisfied at Screening (or at baseline when specified):

• Male or female aged ≥18 and ≤50 years.
• Current diagnosis of schizophrenia or schizoaffective disorder according to DSM-5 criteria as confirmed by the MINI 7.0.2.
• The following psychiatric criteria were used to determine subject eligibility:
• Duration of diagnosis of schizophrenia or schizoaffective disorder of ≥2 years.
• Outpatient; not hospitalized for worsening of schizophrenia within the last 6 months (partial hospitalization for social management within this time period is acceptable).
• Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months.
• Stabilized on an oral antipsychotic medication (single agent) for a minimum of 6 weeks at the time of Screening.
• On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month prior to the Screening visit and for the duration of the study.
• CGI-S score of ≤4 (moderately ill).
• PANSS score of ≤80 points.
• Body mass index (BMI) of ≥18 kg/m2 and ≤35 kg/m2.
• Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
• Willing to comply with all protocol-specified procedures and availability for the duration of the study.
• Subject has identified a caregiver or personal contact with whom the subject communicates with at least once a week.

Exclusion Criteria: Subject will not be considered eligible to participate in this study if any one of the following exclusion criteria is satisfied at Screening (or at baseline when specified):

• Subjects with known clinically significant esophageal or GI disease, including but not limited to:
• Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or subjects with high risk of stricture, e.g., Crohn's disease.
• Diagnosis of a condition known to elevate or lower gastric pH, e.g., achlorhydria or hypochlorhydria.
• Prior varices or small or large bowel obstructions.
• Prior abdominal or upper gastrointestinal surgery (prior uncomplicated laparoscopic procedures including appendectomy or colectomy).
• History of dysphagia or aspiration in the last 5 years.
• History of an esophageal motility disorder or undergoing treatment for a gastric motility disorder.
• Significant history of diarrhea or constipation within 3 months of Screening
• Multiple episodes of abdominal pain within 3 months of Screening.
• Subjects who experience moderate or severe dysmenorrhea or menorrhagia (with use of pain medication) within 3 months of Screening.
• History of moderate to severe Acid Reflux Disease or a score of ≥2 on the Acid Reflux Severity Scale (ARSS) [2], indicating moderate to severe symptoms. The ARSS scale is as follows:

None = 0 no symptoms Mild = 1 awareness of symptom, but easily tolerated Moderate = 2 discomfort sufficient to cause interference with normal activities Severe = 3 incapacitating, with inability to perform normal activities.

• Subjects with PILL-5 questionnaire score of 5 or greater.
• Medical history or current diagnoses indicating the presence of any of the below conditions:
• Presence of an uncontrolled, unstable, clinically significant medical condition could that could put the subject at risk because of participation in the study, interfere with the subject's ability to participate in the study or influence the interpretation of safety or PK evaluations.
• History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure with 6 months of Screening.
• Any clinically significant illness, medical or surgical procedure or trauma within 4