Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Staccato® Loxapine for Inhalation in Subjects on Chronic, Stable Antipsychotic Regimens
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.
研究概览
简要总结
The objectives of this trial are to assess the safety, tolerability, and pharmacokinetics of multiple inhaled doses of Staccato Loxapine.
详细描述
The purpose of the present Phase 1 study in schizophrenic patients is to assess the safety and pharmacokinetics of multiple doses of Staccato Loxapine given within a 24 hour time period. The study will be conducted in schizophrenic patients who are on chronic, stable antipsychotic medication. Patients meeting entry criteria will be randomized to one of three dose sequences of Staccato Loxapine or to Staccato Placebo. Following administration of medications, safety, tolerability and pharmacokinetic assessments will be conducted at serial time points.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
A - 10 mg loxapine q 4 h x 3 (30 mg total)
干预措施: A - 10 mg loxapine q 4 h x 3 (30 mg total) (Drug)
B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total)
干预措施: B - 10 mg x 1, 5 mg x 2 loxapine q 4 h (20 mg total) (Drug)
C - 5 mg loxapine q 4 h x 3 (15 mg total)
干预措施: C - 5 mg loxapine q 4 h x 3 (15 mg total) (Drug)
D - inhaled placebo q 4 h x 3
干预措施: D - inhaled placebo q 4 h x 3 (Drug)
结局指标
主要结局
PK parameters: tmax, Cmax, AUClast, AUCinf, ke, t1/2 and clearance will be estimated for each subject and for the population using noncompartmental methods.
时间窗: 48 hours
次要结局
- Plasma concentration-time (PK) profiles will be produced for each subject and a mean PK profile for subjects completing for each dose group(24 hours)
- Tolerability will be assessed based on treatment emergent adverse events, vital signs, ECG and a visual-analog sedation scale.(24 hours)