Pharmacokinetics, Safety and Tolerability of Different Formulations and Dose Strengths of Quarterly Risperidone (QUAR) in Patients With Schizophrenia
This is a single ascending dose phase 1 study to evaluate the pharmacokinetics (PK), safety, and tolerability of a single intramuscular (IM) injection of quarterly Risperidone (QUAR) for different formulations and dose strengths in participants with schizophrenia.
- EligibilityCriteria: Inclusion Criteria:  Capable of providing informed consent. Male or female aged ≥ 18 years to < 65 years with BMI ≥17.0 to ≤35.0 kg/m2 Current diagnosis of schizophrenia, according to the Diagnostic and DSM-5 criteria. Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment currently taking oral risperidone as maintenance therapy Score of ≤ 4 (moderately ill at most) on the Clinical Global Impression - Severity of Illness (CGI-S) If a sexually active female of childbearing potential, using a medically accepted method of birth control.  Exclusion Criteria:  Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator could interfere with the interpretation of safety and PK evaluations If female, a positive serum pregnancy test, or planning to become pregnant between signing informed consent and 1 month after the last dose of study drug or is breastfeeding a child. History of neuroleptic malignant syndrome and current or past history of clinically significant tardive dyskinesia. The participant has a primary diagnosis other than schizophrenia diagnosis that is primarily responsible for current symptoms and functional impairment Positive test result for drugs of abuse or alcohol unless the positive finding can be accounted for by documented prescription use. In the investigator's opinion, at imminent risk of committing self-harm or harm to others. Unwilling to discontinue any of the prohibited medications prior to the baseline visit or unable to safely washout such medication without significant destabilization or increased risk of self-harm (suicide). Receipt study drug in another investigational study in the last 90 days. Current participation in any other clinical trial. - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 65 Years - StdAgeList: Adult, Older Adult