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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01942382
First received: September 10, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate
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: Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Plasma concentration of unchanged drug (Paliperidone palmitate) [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
  • Plasma concentration of active metabolite (paliperidone) [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
  • Plasma concentration of enantiomer of paliperidone palmitate (R078543) [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
  • Plasma concentration of enantiomer paliperidone palmitate (R078544) [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
    The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.

  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Days 1 to 190 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 190 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) [ Time Frame: Screening, Baseline (Day 1), Days 8, 36, 64, and 92 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Screening, Baseline (Day 1), Days 8, 36, 64, and 92 ] [ Designated as safety issue: No ]
    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.


Enrollment: 76
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Drug: Paliperidone palmitate
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.
Other Name: JNS010
Experimental: Treatment B
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
Drug: Paliperidone palmitate
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.
Other Name: JNS010
Experimental: Treatment C
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
Drug: Paliperidone palmitate
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.
Other Name: JNS010

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01942382

Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01942382     History of Changes
Other Study ID Numbers: CR100413, PALM-JPN-3
Study First Received: September 10, 2013
Last Updated: September 10, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Schizophrenia
JNS010
Paliperidone Palmitate
Clinical Pharmacology

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

ClinicalTrials.gov processed this record on November 25, 2014