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

Condition(s) targeted: Schizophrenia; Schizoaffective Disorder

Intervention: Risperidone ISM 50 mg (Drug); Risperidone ISM 75 mg (Drug); Risperidone ISM 100 mg (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Rovi Pharmaceuticals Laboratories

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

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Area under the curve

Detailed description: 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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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

TBD, Croatia

TBD, Russian Federation

TBD, South Africa

TBD, Spain

Starting date: April 2013
Last updated: October 6, 2014