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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Paliperidone palmitate
Sponsored by
Janssen Pharmaceutical K.K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, JNS010, Paliperidone Palmitate, Clinical Pharmacology

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:- Participants had to have the capability to provide informed consent in writing to participate in the study

  • 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

Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Treatment A

    Treatment B

    Treatment C

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Plasma concentration of unchanged drug (Paliperidone palmitate)
    Plasma concentration of active metabolite (paliperidone)
    Plasma concentration of enantiomer of paliperidone palmitate (R078543)
    Plasma concentration of enantiomer paliperidone palmitate (R078544)
    Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
    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.
    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.
    Number of participants with adverse events

    Secondary Outcome Measures

    Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
    The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
    Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.

    Full Information

    First Posted
    September 10, 2013
    Last Updated
    September 10, 2013
    Sponsor
    Janssen Pharmaceutical K.K.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01942382
    Brief Title
    A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
    Official Title
    Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    March 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Janssen Pharmaceutical K.K.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    This is a multicenter (study conducted at multiple sites), open label (all people know the identity of the intervention), randomized (the study medication is assigned by chance), parallel-group (each group of participants will be treated at the same time) study. Approximately, 60 participants will be enrolled in the study. This study will consist of a screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98 days). Participants will be randomly assigned to treatment group A, B, or C. During the observation phase, participants will receive injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal muscle as applicable on Days 1, 8, 36, and 64 alternating between sides (left/right). Safety evaluations will include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the study. The total study duration for each participant will be approximately 190 days.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Schizophrenia
    Keywords
    Schizophrenia, JNS010, Paliperidone Palmitate, Clinical Pharmacology

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment A
    Arm Type
    Experimental
    Arm Description
    Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
    Arm Title
    Treatment B
    Arm Type
    Experimental
    Arm Description
    Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
    Arm Title
    Treatment C
    Arm Type
    Experimental
    Arm Description
    Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
    Intervention Type
    Drug
    Intervention Name(s)
    Paliperidone palmitate
    Other Intervention Name(s)
    JNS010
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Plasma concentration of unchanged drug (Paliperidone palmitate)
    Time Frame
    Days 1 to 190
    Title
    Plasma concentration of active metabolite (paliperidone)
    Time Frame
    Days 1 to 190
    Title
    Plasma concentration of enantiomer of paliperidone palmitate (R078543)
    Time Frame
    Days 1 to 190
    Title
    Plasma concentration of enantiomer paliperidone palmitate (R078544)
    Time Frame
    Days 1 to 190
    Title
    Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
    Description
    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
    Time Frame
    Days 1 to 190
    Title
    Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate
    Description
    The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
    Time Frame
    Days 1 to 190
    Title
    Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate
    Description
    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.
    Time Frame
    Days 1 to 190
    Title
    Number of participants with adverse events
    Time Frame
    Up to Day 190
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
    Description
    The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill). Higher scores indicate worsening.
    Time Frame
    Screening, Baseline (Day 1), Days 8, 36, 64, and 92
    Title
    Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score
    Description
    The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
    Time Frame
    Screening, Baseline (Day 1), Days 8, 36, 64, and 92

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria:- Participants had to have the capability to provide informed consent in writing to participate in the study 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 Exclusion Criteria:- DSM-IV-TR diagnosis other than schizophrenia 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janssen Pharmaceutical K.K., Japan Clinical Trial
    Organizational Affiliation
    Janssen Pharmaceutical K.K.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=2965&filename=CR100413_CSR.pdf
    Description
    Clinical pharmacology study of JNS010 (Paliperidone palmitate) in patients with schizophrenia

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