A Study of Paliperidone Blood Concentrations in Patients With Schizophrenia After Administration of Paliperidone Palmitate

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT01110317
First received: April 22, 2010
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

The purpose of this study is to evaluate the concentration of paliperidone in the blood after intramuscular injection in upper arm (deltoid muscle) or in the buttock (gluteal muscle) in patients with schizophrenia.


Condition Intervention Phase
Schizophrenia
Drug: paliperidone palmitate 100 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-Label, Parallel, Randomized, Multiple-Dose Pharmacokinetic Study of Paliperidone After Intramuscular Injection of Paliperidone Palmitate in the Deltoid or Gluteal Muscle in Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Determination of the concentration of paliperidone in blood samples obtained from patients. [ Time Frame: Predose at specified time points (Days 18, 20, 22, 29, 46, 50, 85, 92, 99, 106, 120, 134, 148, 162, and 176) during the study through Day 176 or the time of early withdrawal from the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety of paliperidone palmitate i.m. injections in patients will be evaluated by injection site evaluations, clinical laboratory tests, vital signs measurements, and physical examinations. [ Time Frame: From time of screening (Visit 1) through the end of study (Visit 33 [Day 176]) or at the time of early withdrawal from the study ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: July 2005
Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: 001
paliperidone palmitate 100 mg Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1 8 36 and 64.
Drug: paliperidone palmitate 100 mg
Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.

Detailed Description:

This is a an open-label (all patients will know the name of the study drug that they are receiving), randomized (patients will selected by "chance" or like "flipping a coin" to administration of study drug by intramuscular [i.m.] injection into the gluteal [buttocks] or deltoid [upper arm] muscle of the body) study in patients with schizophrenia. A minimum of 40 patients (20 patients per group [1 group of patients to be administered study drug by injection in the gluteal muscle and 1 group of patients to be administered study drug by injection in the deltoid muscle]) will participate in this study, including at least 4 women in each group. The study will consist of a screening period that will occur within 21 days before the first study drug administration, an open-label treatment period during which patients will receive a total of 4 injections of study drug (paliperidone palmitate) either in the deltoid or gluteal muscle, and an end-of-study visit where final study evaluations will be performed. At the screening visit, if a patient has been treated with an antipsychotic medication before study entry, the medication may be continued during the study except for medications specified in the exclusion criteria for the study. If patients have not been previously treated with 1 of the following antipsychotic drugs: risperidone, paliperidone, or paliperidone palmitate, they will undergo a 4-day evaluation period where they will be given a 3 mg/day dose of an extended release (ER) formulation of paliperidone to evaluate their ability to tolerate study drug. Patients who meet all entry criteria for the study will be randomly assigned to 1 of 2 treatment groups in which they will receive 100 mg equivalent of paliperidone palmitate by i.m. injection in either the gluteal muscle or the deltoid muscle. Blood samples for pharmacokinetics (ie, to test the concentration of study drug in the blood) will be collected at specified times before and after each dose of study drug. A single blood sample may also be collected at any time during screening or before the first day of i.m. administration of study drug for patients who agree to participate in an optional part of the study called a pharmacogenomic evaluation which is an evaluation where genetic information obtained from the patient's blood is used to predict whether or not study drug will help make the patient well. During the study, the patient's psychiatric symptoms, severity of symptoms, and injection site reactions will be evaluated. The primary outcome measure in the study will be the determination of the concentration of paliperidone in the patient's blood before study drug administration at protocol-specified time points during the study. The patient's safety will be monitored throughout the study by performing physical examinations, vital signs measurements, clinical laboratory tests, electrocardiograms (ECGs), monitoring of extrapyramidal symptoms (ie, symptoms that can be associated with taking antipsychotic medications), injection site evaluations, and recording of adverse events (side effects). Each patient will receive a total of 4 paliperidone palmitate 100 mg equivalent injections in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) for more than 1 year that is clinically stable with no change in current antipsychotic medications for 3 months prior to screening
  • Have a total Positive and Negative Syndrome Scale for Schizophrenia (PANSS) score of 70 or less, a score of no more than 16 points on the sum of the following 4 items of the PANSS: conceptual disorganization, suspiciousness/persecution, hallucinatory behavior, and unusual thought content, and scores not greater than 5 on any of the individual items of the PANSS
  • Be otherwise healthy confirmed by prestudy physical examination, 12-lead electrocardiogram (ECG), vital signs, and clinical laboratory tests
  • Sign an informed consent document indicating an understanding of the purpose and procedures required for the study and a willingness to participate in the study

Exclusion Criteria:

  • Have a DSM-IV diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence, within 12 months prior to screening
  • Be involuntarily-hospitalized or plan to undergo surgery/procedures during the course of the study
  • Take the following prohibited medications: oral risperidone within 2 weeks of randomization, oral paliperidone within 2 weeks of randomization with the exception of the tolerability testing period, clozapine therapy within 6 weeks of randomization, use of ziprasidone and thioridazine within 1 week prior to randomization, risperidone within 100 days of screening, a paliperidone palmitate long-acting preparation within 10 months of randomization, long-acting formulations of other neuroleptic drugs within 1 treatment cycle before screening, barbiturates within 14 days prior to randomization, any anticonvulsant medications within 14 days prior to randomization, or use of irbesartan within 1 week prior to randomization
  • Have a history of an allergic reaction to risperidone, paliperidone, or any of their excipients, or have a known hypersensitivity to risperidone or paliperidone
  • Have current thoughts of suicide (suicidal ideation) or violent tendencies at the time of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110317

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided

Responsible Party: Associate Director, Clinical Pharmacoloy, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT01110317     History of Changes
Other Study ID Numbers: CR002362, R092670PSY1001
Study First Received: April 22, 2010
Last Updated: April 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Paliperidone palmitate
R092670PSY1001
Pharmacokinetics
Risperdal (CONSTA)
Risperidone, Paliperidone

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
9-hydroxy-risperidone
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 30, 2014