A Pharmacokinetic and Safety Study of Paliperidone Palmitate (JNS010) in Participants With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Paliperidone palmitate (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K., Japan Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

The purpose of this study is to assess the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) and safety of paliperidone palmitate in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Official title: A Repeated Dose Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia

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

Primary outcome:

Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 8

Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 36

Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 64

Paliperidone Pre-dose Plasma Concentration (Cpredose) at Day 92

Maximum Observed Plasma Concentration (Cmax) of Paliperidone

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Paliperidone

Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau)

Plasma Paliperidone Concentration at Steady State (Css av)

Paliperidone Plasma Decay Half-Life (t1/2)

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 8

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 22

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 50

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 78

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 92

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 120

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 162

Number of Participants With Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Score at Day 218

Secondary outcome:

Positive and Negative Syndrome Scale (PANSS) Total Score

Number of Participants With Clinical Global Impression Severity (CGI-S) Score

Detailed description: This is a multicenter (when more than one hospital or medical school team work on a medical research study), open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), parallel-group (Each group of participants will be treated at the same time), comparison study to assess the pharmacokinetics and safety of paliperidone palmitate (study medication) in participants with schizophrenia. The study comprises a 64-day Treatment period and a 155-day Follow-up period. The participants will be randomly assigned to one of the four study groups. The study medication will be administered on Days 1, 8, 36 and 64. Pharmacokinetics of the study medication will be assessed as primary outcome. Participants' safety will be monitored throughout the study.

Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Participants who have been diagnosed with schizophrenia in accordance with the

diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

- Participants may be inpatients or outpatients

- Participants who have been taking an oral antipsychotic medication for at least 28

days before the date of informed consent

- Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than

or equal to 4 (moderate) at screening

- Participants who have taken risperidone by the start of investigational treatment and

the record can be confirmed Exclusion Criteria

- Participants who have been diagnosed with a mental disease other than schizophrenia

in accordance with the diagnostic criteria of Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV)

- Participants who have been diagnosed with substance-related disorders (except

nicotine and caffeine dependence)

- Participants with complicated parkinson's disease (a progressive disorder of the

central nervous system, seen usually in older persons, in which there is muscle weakness, trembling and sweating)

- Participants with a complication of or with a history of convulsive disease such as

epilepsy (seizure disorder)

- Participants with a complication of or with a history of cerebro-vascular accident

(stroke), neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness) or physical exhaustion associated with the state of dehydration (lose of water and minerals in the body) or malnutrition

Ichikawa, Japan

Starting date: January 2007
Last updated: May 28, 2013