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This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Full description
This is a randomized, single-dose, open-label, parallel-group study. Patients will undergo the screening evaluations to determine eligibility within 28 days prior to study drug administration. Approximately 80 eligible patients will be randomized in a 1:1:1:1 ratio to 1 of 4 treatment groups.
Patients will be admitted to the clinical facilities the day (Day 0) before dosing, and will be randomized and receive a single dose on Day 1. Patients will be discharged on Day 2 after PK collection. All patients will return to the clinical site at designated study days for PK sample collections and assigned clinical procedures (Table 1). End of study evaluation will be completed on Day 176 or at early withdrawal.
For patients who have never taken paliperidone or risperidone, tolerability will be tested with oral risperidone (1 mg risperidone taken orally for 3 consecutive days) at Screening approximately 14 days but no less than 9 days prior to dosing.
Enrollment
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Inclusion criteria
To participate in the study, patients must meet all inclusion criteria at screening:
Exclusion criteria
Primary and active DSM-V Axis I diagnosis other than schizophrenia or Schizoaffective disorder.
Patients who meet DSM-V criteria for substance abuse (moderate or severe), or test positive for a drug of abuse or alcohol at screening or baseline with the exception of test positive for barbiturate or benzodiazepine which can be accounted for by documented prescriptions from a treating physician as a part of the treatment for the patient's underlying medical conditions.
Patients who received any of the following treatment(s):
Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, or any of their excipients (oral risperidone tolerability test will be completed during the screening period, approximately14 days but no less than 9 days prior to dosing, for patients without documented evidence [medical record or written statement from a licensed medical practitioner who has treated the patient] of tolerating risperidone or paliperidone, and patients who show an allergic reaction to this test will be excluded from the study).
Patients who pose a significant risk of a suicide attempt based on history or the Investigator's judgment; answer "yes" to Suicidal Ideation items 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) for current or past 6 months on the "Baseline/Screening version" at screening; have had suicidal behavior in the last 6 months as measured by the C-SSRS at screening; or are at imminent risk of suicide or violent behavior based on the Investigator's clinical assessment or the C-SSRS assessment of lifetime suicidal ideation or behavior at screening.
Any one or more of the following 3 conditions: (i) clinically significant liver dysfunction, (ii) hepatitis B surface antigen (HBsAg) positive, hepatitis C (HCV) positive, or (iii) a serum alanine transaminase (ALT) or aspartate transaminase (AST) > 2 x upper limit of normal (ULN) range; or a total bilirubin > 1.5 x ULN (if the ALT or AST levels are between 2x and 3x ULN in the first screening test and the elevation may be caused by non-specific reasons in the judgment of the Investigator, a second test can be performed after one week. If the repeated ALT or AST levels are still >2 x ULN, the patient must be excluded from the study. Patients who are HCV antibody reactive but confirmed HCV RNA not detected may be enrolled, if this condition has been previously considered stable without treatment or after the completion of appropriate treatment, and liver function is normal.
History of symptomatic orthostatic hypotension or with a decrease of ≥ 20 mmHg in systolic blood pressure (SBP) or decrease of ≥10 mmHg in diastolic blood pressure (DBP) when changing from supine to standing position after having been in the supine position for at least 5 minutes or SBP less than 105 mmHg in a supine position at screening or prior to randomization.
Uncontrolled diabetes or hemoglobin A1c (HbAlc) level ≥7% at screening.
Indication of impaired renal function at Screening (estimated glomerular filtration rate < 80 mL/min).
History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia; history of severe akathisia or extra-pyramidal reactions such as dystonia with previous use of risperidone or other neuroleptic treatments; score ≥ 3 on the Global Clinical Assessment of the BARS or score ≥ 2 on the AIMS at screening
QTcF interval greater than 450 msec for males and 460 msec for females at screening, or other clinically significant ECG findings in the opinion of the Investigator.
Clinically significant past medical history (within 2 years) of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, renal, hepatic, bronchopulmonary, neurologic, immunologic disorders, or drug hypersensitivity which, in the judgment of the Investigator, would interfere with the patient's ability to participate in the study.
Patient has clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19), e.g., fever, dry cough, dyspnea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 30 days prior to screening or on admission.
Patient who had severe course of COVID-19 (i.e., hospitalization, extracorporeal membrane oxygenation (ECMO), and/or mechanically ventilated).
Patients who have received COVID-19 vaccines within the last 14 days prior to baseline or plan to get vaccinated within 30 days after dosing.
Malignancies within 5 years with the exception of cured basal cell or squamous cell skin cancer or in situ cervical cancer prior to screening.
History or current diagnosis of epilepsy or convulsive disorder other than a single childhood febrile seizure.
History or current diagnosis of Parkinson's diseases, Dementia with Lewy Bodies or other Dementia-related psychosis.
Receipt of another investigational product within 1 month, or 5 half-lives of the other investigational product, whichever is longer, prior to screening.
Donation or blood collection of > 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening.
Clinical Laboratory at screening indicating white blood cells <3x109/L, or neutrophils <1.5x109/L or platelets < 80 x109/L.
Has a prolactin laboratory value ≥ 100 ng/ml at screening.
Human immunodeficiency virus (HIV) test positive.
Any clinical observation or clinical laboratory abnormality findings at screening or baseline visits which, in the opinion of the Investigator, may endanger the patient or interfere with the endpoints of the study. If the results of clinical laboratory testing (unless specified) are outside normal reference ranges, the patient may be enrolled but only if these findings are determined not to be clinically significant by the Investigator. This determination must be recorded in the patient's source documents.
Primary purpose
Allocation
Interventional model
Masking
89 participants in 4 patient groups
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Central trial contact
Rui Li
Data sourced from clinicaltrials.gov
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