A Randomized, Double Blind, Placebo Controlled, Three- Period Crossover Study Comparing the Acute Effects of Orally Inhaled Dihydroergotamine (DHE), Oral Moxifloxacin, and Placebo on QT Intervals in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
研究概览
简要总结
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide a signed, executed written informed consent
- •Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old
- •Female subjects who are practicing adequate contraception (see section 4.4) or who are sterile
- •No known cardiac disease
- •Normal hemoglobin values
- •Normal or not clinically significant 12-lead Electrocardiogram
- •Heart rate ≥ 40 and ≤ 100 at Visit 1 vital signs assessment (resting)
- •Subjects with QTcF interval duration <430 msec for males and <450 msec for females obtained from the ECG recorder's measurements on the screening ECG taken after at least 5 minutes of quiet rest in supine position
- •Demonstrated ability to properly use the Tempo® Inhaler
- •Subject has not donated blood in the last 56 days
排除标准
- •Contraindication to dihydroergotamine mesylate (DHE)
- •History of hemiplegic or basilar migraine
- •Family history of long QT syndrome
- •Participation in another investigational trial during the 30 days prior to Visit 1
研究组 & 干预措施
Treatment A, then Treatment B, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment A, then Treatment B, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment A, then Treatment B, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment A, then Treatment B, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
Treatment A, then Treatment C, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment A, then Treatment C, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment A, then Treatment C, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment A, then Treatment C, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.
Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
Treatment B, then Treatment A, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment B, then Treatment A, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment B, then Treatment A, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment B, then Treatment A, then Treatment C
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
Treatment B, then Treatment C, then Treatment A
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment B, then Treatment C, then Treatment A
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment B, then Treatment C, then Treatment A
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment B, then Treatment C, then Treatment A
There was 48 hour wash-out between treatment visits. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
Treatment C, then Treatment A, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment C, then Treatment A, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment C, then Treatment A, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment C, then Treatment A, then Treatment B
There was 48 hour wash-out between treatment visits. Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.
Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4. Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
Treatment C, then Treatment B, then Treatment A
There was 48 hour wash-out between treatment visits.
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: MAP0004 (Drug)
Treatment C, then Treatment B, then Treatment A
There was 48 hour wash-out between treatment visits.
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Inhaler Placebo (Drug)
Treatment C, then Treatment B, then Treatment A
There was 48 hour wash-out between treatment visits.
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Moxifloxacin (Drug)
Treatment C, then Treatment B, then Treatment A
There was 48 hour wash-out between treatment visits.
Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
Tablets were orally administered after oral inhalation dosing.
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Change From Baseline in QTcI for MAP0004 3.0mg and Placebo at 30 Minutes
时间窗: baseline and 30 minutes
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
Change From Baseline in QTcI for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours
时间窗: baseline and 2 hours
The corrected QT interval, individualized (QTcI) is a measurement of the electrical impulses through the largest part of the heart muscle individualized for subject pre-dose values. A negative change is a shortening of the QTc interval, a positive change is a lengthening of the QTc interval.
次要结局
- Change From Baseline in QTcF for MAP0004 3.0mg and Placebo at 30 Minutes(baseline and 30 minutes)
- Change From Baseline in QTcF for MAP0004 3.0mg, Placebo, and Moxifloxacin at 2 Hours(baseline and 2 hours)
- Change From Baseline in Heart Rate for MAP0004 3.0mg, Placebo, and Moxifloxacin at 30 Minutes and 2 Hours(baseline, 30 minutes, and 2 hours)