Clinical trial NCT01942382: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
JNS010
Paliperidone Palmitate
Clinical Pharmacology
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2013-09-16
Enrollment: 76
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Plasma concentration of unchanged drug (Paliperidone palmitate)
timeFrame: Days 1 to 190
measure: Plasma concentration of active metabolite (paliperidone)
timeFrame: Days 1 to 190
measure: Plasma concentration of enantiomer of paliperidone palmitate (R078543)
timeFrame: Days 1 to 190
measure: Plasma concentration of enantiomer paliperidone palmitate (R078544)
timeFrame: Days 1 to 190
measure: Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
timeFrame: Days 1 to 190
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate
timeFrame: Days 1 to 190
measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate
timeFrame: Days 1 to 190
measure: Number of participants with adverse events
timeFrame: Up to Day 190
Secondary outcomes:
measure: Change from baseline in Positive and Negative Syndrome Scale for Schizophrenia (PANSS)
timeFrame: Screening, Baseline (Day 1), Days 8, 36, 64, and 92
measure: Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score
timeFrame: Screening, Baseline (Day 1), Days 8, 36, 64, and 92
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: