NCT04712734已完成1 期
An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With 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
- 42
- 试验地点
- 1
- 主要终点
- Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.
研究概览
简要总结
This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Willing and able to provide written informed consent.
- •Male or female patients 18 to 65 years of age (inclusive).
- •Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
- •Symptomatically stable within the past two months.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
- •Pregnant or nursing (lactating) women.
- •A positive test for drugs of abuse.
研究组 & 干预措施
Iloperidone
Experimental
干预措施: Iloperidone (Drug)
结局指标
主要结局
Assessment of safety and tolerability of repeat-dosing of iloperidone given as a long-acting injection.
时间窗: 24 weeks
As measured by spontaneous reporting of adverse events (AEs).
Pharmacokinetics of iloperidone and its metabolites following repeat-dosing of iloperidone given as a long-acting injection.
时间窗: 24 weeks
As measured by plasma concentrations.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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