Thorough QT/QTc Study 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
- 48
- 试验地点
- 2
- 主要终点
- Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
研究概览
简要总结
The purpose of the present Phase 1 study was to assess the cardiac safety of Staccato Loxapine administered to healthy volunteers in a 3 period crossover study.
详细描述
Primary Objective: To assess the maximum effect of Staccato Loxapine on cardiac repolarization (QTc interval duration) at the anticipated maximum clinical dose compared to placebo in healthy volunteers.
Secondary Objective: To assess the QTc versus loxapine concentration relationship following treatment with Staccato Loxapine 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)
盲法说明
Double blind, double dummy
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
- •Subjects who are in good general health and agree to use a medically acceptable and effective birth control method throughout the study.
排除标准
- •Subjects who have taken prescription or nonprescription medication within 5 days of treatment,
- •Subjects who have had an acute illness within the last 5 days of treatment,
- •Subjects who are smokers, OR
- •Subjects who have an ECG abnormality at baseline.
研究组 & 干预措施
Treatment sequence ABC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence ABC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence BCA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
Treatment sequence ACB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence ACB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
Treatment sequence BCA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence ACB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence ACB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence BCA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence BCA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence BAC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence BAC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence CAB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence CAB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence CBA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled placebo (Drug)
Treatment sequence CBA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral placebo (Drug)
Treatment sequence ABC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence ABC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
Treatment sequence BAC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence BAC
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
Treatment sequence CAB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence CAB
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
Treatment sequence CBA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Inhaled loxapine (Drug)
Treatment sequence CBA
Treatment: A = Inhaled loxapine 10 mg, B = Placebo, C = Oral moxifloxacin 400 mg
干预措施: Oral moxifloxacin (Drug)
结局指标
主要结局
Maximum Effect of ADASUVE on Cardiac Repolarization (QTc Interval Duration) at the Maximum Clinical Dose Compared to Placebo
时间窗: 1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours
Largest of the upper CIs of the time matched differences in QTcI values between the maximum of the mean difference from baseline of the QTcI interval after time matched placebo subtraction for ADASUVE treatment at 12 prespecified post inhalation times
次要结局
- Numbers and % of Subjects With QTcI Change > 30 ms(1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours)
- Cardiac Repolarization Change (QTcI) Versus Loxapine Concentration Relationship Following Treatment With Staccato Loxapine in Healthy Volunteers.(24 hours)
- Numbers and % of Subjects With QTcI > 450 ms(1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours)
- Numbers and % of Subjects With QTcI Change > 60 ms(1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours)
- Numbers and % of Subjects With QTcI > 480 ms(1, 2, 5, 9, 15, 30 min, 1, 3, 6, 10 and 23 hours)