Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 76
- 主要终点
- Plasma concentration of unchanged drug (Paliperidone palmitate)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment A
Participants will receive 4 injections of paliperidone palmitate 150 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
干预措施: Paliperidone palmitate (Drug)
Treatment B
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the deltoid muscle on Days 1, 8, 36, and 64.
干预措施: Paliperidone palmitate (Drug)
Treatment C
Participants will receive 4 injections of paliperidone palmitate 75 milligram in the gluteal muscle on Days 1, 8, 36, and 64.
干预措施: Paliperidone palmitate (Drug)
结局指标
主要结局
Plasma concentration of unchanged drug (Paliperidone palmitate)
时间窗: Days 1 to 190
Plasma concentration of active metabolite (paliperidone)
时间窗: Days 1 to 190
Plasma concentration of enantiomer of paliperidone palmitate (R078543)
时间窗: Days 1 to 190
Plasma concentration of enantiomer paliperidone palmitate (R078544)
时间窗: Days 1 to 190
Time to Reach Maximum Observed Plasma Concentration (Tmax) of paliperidone palmitate
时间窗: Days 1 to 190
The Tmax is defined as actual sampling time to reach maximum observed analyte concentration.
Maximum Observed Plasma Concentration (Cmax) of paliperidone palmitate
时间窗: Days 1 to 190
The Plasma Concentration (Cmax) is defined as maximum observed analyte concentration.
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of paliperidone palmitate
时间窗: Days 1 to 190
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
时间窗: Up to Day 190
次要结局
- 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)