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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Risperidone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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