A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia

NCT01942382 | Completed Phase 1

• 2 other identifiers: CR100413PALM-JPN-3
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.

Conditions

Schizophrenia

Keywords

Schizophrenia; JNS010; Paliperidone Palmitate; Clinical Pharmacology

Outcome Measures

Primary Outcomes (8)

• Plasma concentration of unchanged drug (Paliperidone palmitate)

  Days 1 to 190

• Plasma concentration of active metabolite (paliperidone)

  Days 1 to 190

• Plasma concentration of enantiomer of paliperidone palmitate (R078543)

  Days 1 to 190

• Plasma concentration of enantiomer paliperidone palmitate (R078544)

  Days 1 to 190

• Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate

  The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

  Days 1 to 190

• Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate

  The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.

  Days 1 to 190

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

  The Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) is a measure of the plasma paliperidone concentration from time zero to end of dosing interval. It is used to characterize drug absorption.

  Days 1 to 190

• Number of participants with adverse events

  Up to Day 190

Secondary Outcomes (2)

• Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

  Screening, Baseline (Day 1), Days 8, 36, 64, and 92

• Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score

  Screening, Baseline (Day 1), Days 8, 36, 64, and 92

Study Arms (3)

Treatment A

EXPERIMENTAL

Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.

Drug: Paliperidone palmitate

Treatment B

EXPERIMENTAL

Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.

Drug: Paliperidone palmitate

Treatment C

EXPERIMENTAL

Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate DRUG

Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.

Also known as: JNS010

Treatment A; Treatment B; Treatment C

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with a diagnosis of schizophrenia in accordance with the diagnostic criteria for Diagnostic and Statistical Manual of Mental Disorders -IV-TR (DSM-IV-TR)
• Participants whose psychiatric symptom is considered stable by the investigator/subinvestigator at the time of giving informed consent
• Participants with a Positive and Negative Syndrome Scale (PANSS) score of less than or equal to 4 (moderate) in the following 9 items at screening: delusion, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, hostility, uncooperativeness, poor impulse control
• Participants with an experience of taking a risperidone formulation or a paliperidone formulation by 8 days before the initial day (Day 1) of the study treatment

You may not qualify if:

• DSM-IV-TR diagnosis of substance-related disorders within 180 days before the date of screening
• At a risk of suicide or other-injurious behavior as considered by the investigator/subinvestigator , and participants with a history of suicide attempts
• Concurrent condition of Parkinson's disease (except for drug-induced extrapyramidal syndrome) - Concurrent condition or history of symptomatic cerebrovascular accident

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Related Links

• Clinical pharmacology study of JNS010 (Paliperidone palmitate) in patients with schizophrenia

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 10, 2013
• First Posted: September 16, 2013
• Study Start: April 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 16, 2013

Record last verified: 2013-09