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Pharmacokinetics and Tolerability Study of Risperidone ISM® in Schizophrenia

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

Intervention: Risperidone ISM (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Rovi Pharmaceuticals Laboratories

Summary

To characterize the pharmacokinetics (PK) of the injectable intramuscular (IM) long-acting formulation (in situ microparticle, ISM) of risperidone over four IM injections in the gluteal and deltoid muscle at 28-day intervals and at one dose strength (75 mg) in patients with schizophrenia.

Clinical Details

Official title: Multicenter, Open-label, Two-arm, Parallel-design, Repeat-dose Clinical Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Four Intramuscular Injections of Risperidone ISM 75 mg, at 28 Day Intervals in Patients With Schizophrenia

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

Primary outcome:

Peak Plasma Concentration (Cmax) for Active Moiety

Trough Plasma Concentration (Cmin) for Active Moiety

Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Active Moiety

Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Active Moiety

Secondary outcome:

Peak Plasma Concentration (Cmax) for Risperidone and 9OH-Risperidone Moieties

Trough Plasma Concentration (Cmin) for Risperidone and 9OH-Risperidone Moieties

Occurrence, nature, onset time, duration, intensity, action taken, outcome and relationship to study drug of AEs as a Measure of Safety

Area under the curve to the last quantified concentration (AUClast) and Area under the curve extrapolated to infinity (AUC∞) for Risperidone and 9OH-Risperidone Moieties

Terminal rate constant (λz), Terminal half-life (t1/2) and Time to peak concentration (tmax) for Risperidone and 9OH-Risperidone Moieties

Area Under the Concentration-time Curve​ for To perform a descriptive comparison of the PK data between the gluteal and the deltoid muscle administration of the injectable ISM formulation

Eligibility

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

Criteria:

Inclusion Criteria: 1. Capable of providing informed consent. 2. Male or female aged ≥18 years to ≤65 years. 3. Current diagnosis of schizophrenia, according to Diagnostic and Statistical Manual 4. Body mass index (BMI) ≥17 kg/m2 but ≤35 kg/m2. 5. Medically stable over the last month, and psychiatrically stable 6. On oral stable dosage of risperidone ≥4 mg daily as maintenance therapy. 7. Total score ≤70 on the Positive and Negative Syndrome Scale. 8. Using a medically accepted contraceptive method

9. Agrees to washout all prohibited medications prior to baseline (day - 1)

Exclusion Criteria: 1. Informed consent obtained from a third party. 2. Prisoners or patients who are compulsorily detained. 3. Females who are breast-feeding and/or who have a positive pregnancy test. 4. Presence of an uncontrolled, unstable clinically significant medical condition. 5. Positive serology for Hepatitis B, Hepatitis C or anti-HIV 1 and 2 at screening. 6. History of neuroleptic malignant syndrome. 7. Current or past history of tardive dyskinesia. 8. Positive urine drug or alcohol screen finding. 9. Risk of committing self-harm or harm based on Columbia Suicidal Rating Scale. 10. Taking more than one antidepressant. 11. Use of depot antipsychotics within the last three months. 12. Use of strong or moderate cytochrome P450 isoenzyme 3A4inducers 13. Use of electroconvulsive therapy (ECT) within the last three months. 14. Receipt of any investigational drugs within the last three months. 15. Known or suspected allergy or hypersensitivity to risperidone 16. Previous non-responder to risperidone treatment.

Locations and Contacts

St. Louis, Missouri 63118, United States
Additional Information

Starting date: March 2014
Last updated: May 4, 2015

Page last updated: August 23, 2015

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