NCT02320032已完成1 期
A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- T max
研究概览
简要总结
This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of various doses and dosing intervals of aripiprazole lauroxil.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has stable schizophrenia or schizoaffective disorder
- •Has demonstrated ability to tolerate aripiprazole
- •Has been on a stable antipsychotic medication regimen without any changes for at least 2 months prior to screening
- •Has a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
- •Additional criteria may apply
排除标准
- •Is pregnant, breastfeeding, or is planning to become pregnant during the study period
- •Has received aripiprazole lauroxil or IM depot aripiprazole within 6 months, or other long-acting, injectable antipsychotic medication within 3 months
- •Is a danger to himself/herself at screening or upon admission
- •Has a history of or positive test result for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
- •Has a positive urine drug screen at screening or Day 1
- •Additional criteria may apply
研究组 & 干预措施
Aripiprazole Lauroxil - A
Experimental
Intramuscular (IM) injection Dose and Dosing Sequence A
干预措施: Aripiprazole Lauroxil (Drug)
Aripiprazole Lauroxil - B
Experimental
Intramuscular (IM) injection Dose and Dosing Sequence B
干预措施: Aripiprazole Lauroxil (Drug)
Aripiprazole Lauroxil - C
Experimental
Intramuscular (IM) injection Dose and Dosing Sequence C
干预措施: Aripiprazole Lauroxil (Drug)
Aripiprazole Lauroxil - D
Experimental
Intramuscular (IM) injection Dose and Dosing Sequence D
干预措施: Aripiprazole Lauroxil (Drug)
结局指标
主要结局
T max
时间窗: Up to 45 weeks
Time to maximum plasma concentration
AUC 0-last
时间窗: Up to 45 weeks
Area under the plasma-concentration time curve from time zero to the last quantifiable plasma concentration
C max
时间窗: Up to 45 weeks
Maximum plasma concentration
次要结局
- Safety and tolerability will be measured by incidence of adverse events(Up to 45 weeks)
- AUC 0-tau(Up to 45 weeks)
研究者
研究点 (1)
Loading locations...
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