Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths

Study Overview
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Brief Summary
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This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

Detailed Description
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This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population. Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug: Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

Official Title
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Phase I, Open-Label, Randomized, Parallel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of One Intramuscular Injection of Risperidone ISM® at Different Dose Strengths in Subjects With Schizophrenia or Schizoaffective Disorder

Conditions
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Schizophrenia, Schizoaffective Disorder

Intervention / Treatment
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* Drug: Risperidone ISM 50 mg
* Drug: Risperidone ISM 75 mg
* Drug: Risperidone ISM 100 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of providing informed consent. Male or female aged ≥ 18 years to < 65 years Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S) If a sexually active female of childbearing potential, using a medically accepted contraceptive method. Exclusion Criteria: Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use. In the investigator's opinion, at imminent risk of committing self-harm Use of depot antipsychotics within the last three months Receipt of any investigational drugs within the last three months Current participation in any other clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Risperidone ISM 50mg<br>Three different single doses will be evaluated | Drug: Risperidone ISM 50 mg<br> <br> |
| Other: Risperidone ISM 75mg<br>Three different single doses will be evaluated | Drug: Risperidone ISM 75 mg<br> <br> |
| Other: Risperidone ISM 100mg<br>Three different single doses will be evaluated | Drug: Risperidone ISM 100 mg<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve |  | Pre-dose and 18 time points Post-dose will be carried out within a 75 day time frame | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, Safety, Risperidone ISM®, Intramuscular, Schizophrenia