Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths
Information source: Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
Summary
This clinical trial is designed to evaluate different dosages of risperidone ISM, a new
long-acting injectable form.
Clinical Details
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.
Eligibility
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
Locations and Contacts
TBD, Croatia
TBD, Russian Federation
TBD, South Africa
TBD, Spain
Additional Information
Starting date: April 2013
Last updated: October 6, 2014
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