Pulmonary Safety of Repeat Doses of Staccato® Loxapine for Inhalation in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
研究概览
简要总结
The objective of this trial is to assess the pulmonary safety of 2 inhaled doses of Staccato Loxapine within a day.
详细描述
The planned study is a multiple dose, double-blind, placebo-controlled, randomized, 2-sequence, 2-period crossover study investigating pulmonary safety in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 是
入选标准
- •nonsmoker subjects in good general health with normal spirometry at screening AND baseline
排除标准
- •history of asthma, COPD, or any other acute or chronic pulmonary disease or bronchodilator use
研究组 & 干预措施
Inhaled Placebo crossed over to Inhaled Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart
干预措施: Inhaled Placebo (Drug)
Inhaled Placebo crossed over to Inhaled Loxapine
Inhaled Staccato Placebo, 2 inhalations, 8 hours apart; washout of at least 4 days; Inhaled Staccato Loxapine, 10 mg oses x 2, 8 hours apart
干预措施: Inhaled Loxapine (Drug)
Inhaled Loxapine crossed over to Inhaled Placebo
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;
干预措施: Inhaled Placebo (Drug)
Inhaled Loxapine crossed over to Inhaled Placebo
Inhaled Staccato Loxapine, 10 mg doses x 2, 8 hours apart; washout of at least 4 days; Inhaled Staccato Placebo, 2 inhalations, 8 hours apart;
干预措施: Inhaled Loxapine (Drug)
结局指标
主要结局
The Largest Treatment Difference (Loxapine - Placebo) in Change in FEV1 From Baseline by Spirometry
时间窗: 17 post-treatment time points (15 min to 32 hr)
The largest treatment difference (Loxapine - Placebo) across the 17 post-treatment time points (15 min to 32 hr) in FEV1 Change from Same-Period Baseline,
次要结局
- The Largest Treatment Difference (Loxapine - Placebo) in Change in FVC From Baseline by Spirometry(17 post-treatment time points (15 min to 32 hr))