Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia

NCT00821600 | Completed Phase 1

• 1 other identifier: CR015742
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a 4-week long-acting injectable (LAI) formulation of risperidone after single intramuscular (i.m.) injection of 75 mg risperidone LAI in the gluteal muscle.

Conditions

Psychotic Disorders; Schizophrenia

Keywords

Risperidone; Antipsychotic; Pharmacokinetic; Long-acting Injectable

Outcome Measures

Primary Outcomes (1)

• To explore the pharmacokinetics of a 4-week long acting injectable (LAI) formulation of risperidone after single intramuscular (IM) injection of 75 mg in the gluteal muscle.

  Up to 85 days for 4-week LAI formulation of risperidone and up to 96 hrs for immediate release (IR) formulation

Secondary Outcomes (1)

• To explore safety and tolerability of a 4-week LAI formulation of risperidone by monitoring scores on CGI-S, scores on ESRS, AEs, PE, lab values, ECG values and injection site reactions.

  Up to 85 days

Study Arms (1)

001

EXPERIMENTAL

risperidone IR and LAI formulation 1 mg risperidone IR single injection followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection

Drug: risperidone IR and LAI formulation

Interventions

risperidone IR and LAI formulation DRUG

1 mg risperidone IR single injection, followed after 7 to 14 days with 75mg risperidone 4-week-LAI single injection

001

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a diagnosis of schizophrenia
• Clinically stable with no change in current antipsychotic medications
• Meet Positive and Negative Symptom Score (PANSS) and Clinical Global Impression (CGI) score criteria
• Have a body mass index (BMI) between 18 and 35 kilogram (kg)/meter (m)2
• If a woman, is postmenopausal surgically sterile, abstinent, or, if sexually active, is practicing before entry into the study and agrees to practice throughout the study an effective method of birth control
• If a man, agrees to use an adequate contraception method as deemed appropriate by the investigator

You may not qualify if:

• Alcohol or substance dependence, with the exception of nicotine or caffeine dependence
• Involuntarily-committed or unable to provide an informed consent
• Has tardive dyskinesia, History of Neuroleptic Malignant Syndrome
• History of or current clinically significant medical illness
• Treatment with any protocol disallowed therapies
• Clinically significant result from screening laboratory or ECG

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (3)

Unknown Facility

Cerritos, California, United States

Location

Unknown Facility

Santa Ana, California, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Related Links

• Single Dose, Open Label Pilot Study to Explore the Pharmacokinetics, Safety and Tolerability of a Gluteal Intramuscular Injection of a 4 Week Long Acting Injectable Formulation of Risperidone in Subjects With Chronic Stable Schizophrenia

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2009
• First Posted: January 13, 2009
• Study Start: December 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

US (3)