Intramuscular Injections of Risperidone 4-Week Long-Acting Injectable (LAI) Formulation in the Buttock of Subjects With Schizophrenia - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 9, 2009

Last Updated Date

March 26, 2009

Start Date ^†

December 2008

Current Primary Outcome Measures ^†

To explore the pharmacokinetics of a 4-week LAI formulation of risperidone after single i.m. injection of 75 mg in the gluteal muscle.

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00821600 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

To evaluate the safety and tolerability and to explore the feasibility to define an in vitro-in vivo correlation (IVIVC).

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Intramuscular Injections of Risperidone 4-Week Long-Acting Injectable (LAI) Formulation in the Buttock of Subjects With Schizophrenia

Official Title ^†

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

Brief Summary

The purpose of this study is to explore the pharmacokinetics, safety and tolerability of a 4-week LAI formulation of risperidone after single i.m.

injection of 75 mg risperidone LAI in the gluteal muscle.

Detailed Description

An intramuscular injectable formulation of risperidone long-acting formulation is under development with the aim to provide a sustained and stable level of risperidone during each treatment cycle given every 4 weeks. As this formulation is a long acting formulation, subjects will be treated with a 1 mg immediate release formulation in the first week to confirm that the subject does not develop an allergic reaction to the long acting formulation. Each subject receives a total of two injections. The first one is the immediate release formulation and the second one the new long acting formulation.

Eligible subjects can stay on their previous oral medication, no tapering of drugs is needed. Whole blood samples will be collected for the determination of risperidone and 9-hydroxy-risperidone concentrations in plasma. Whole blood samples will be obtained by venipuncture (needle stick) immediately before (pre-dose) and at 5, 10, 20, 30, 45 min, 1, 1.5, 2, 4, 6, 8,12, 16, 24, 36, 48, 72, 96 hours after the 1st injection and at 2, 6, 12, 24, 48, 96 hrs, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 39, 43, 50, 57, 64, 71, 78, 85 days after the 2nd injection of risperidone. Safety will assessed at limited visits throughout the study by monitoring scores of the Clinical Global Impression - Severity (CGI-S), adverse events; changes in clinical laboratory results; extrapyramidal symptoms will be evaluated using the Extrapyramidal Symptom Rating Scale (ESRS); physical examinations; electrocardiograms (ECGs); and patient + investigator evaluation of the injection site.

The study has two periods. In the first period all patients will receive one injection of 1 mg risperidone IR (immediate release) solution (liquid). The follow-up duration is 96 hours. In the second period, patients will receive one injection of risperidone 4-week formulation of 75 mg. The follow-up duration is 85 days. The injections in Period 1 and Period 2 will be given in the buttocks muscle (upper, outer side near the hip), separated by a 7 to 14 days wash-out.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Condition ^†

Schizophrenia
Risperidone, Psychotic Disorders

Intervention ^†

Drug: risperidone 4-week LAI formulation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patients with a diagnosis of schizophrenia
Clinically stable with no change in current antipsychotic medications
Meet PANSS and 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

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00821600

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

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

Collaborators ^††

Investigators ^†

Study Director:

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

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

Information Provided By

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

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.