An Open-Label, 2-Period, Crossover Phase 2 Study Comparing the Pharmacokinetics and Tolerability of Dihydroergotamine Mesylate (DHE) Delivered Intravenously (DHE 45) and by Oral Inhalation (MAP0004) in Smoking and Non-Smoking Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers
研究概览
简要总结
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.
Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.
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
- None
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 written informed consent
- •Male or Female subjects 18 to 45 years old
- •Female subjects who are practicing adequate contraception or who are sterile
- •Stable cardiac status
- •Normal rhythm or arrhythmia deemed clinically insignificant on ECG
排除标准
- •Contraindication to dihydroergotamine mesylate (DHE)
- •Use of any excluded concomitant medications within the 10 days prior to Visit 1 (See Section 5.5)
- •History of hemiplegic or basilar migraine
- •Participation in another investigational trial during the 30 days prior to Visit 1 or during this trial
研究组 & 干预措施
IV DHE then MAP0004
Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
干预措施: MAP0004 (Drug)
IV DHE then MAP0004
Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3.
干预措施: IV DHE (Drug)
MAP0004 then IV DHE
Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.
干预措施: MAP0004 (Drug)
MAP0004 then IV DHE
Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.
干预措施: IV DHE (Drug)
结局指标
主要结局
Cmax of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers Versus Non-smokers
时间窗: 48 hours
The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Dihydroergotamine is reported in picograms per milliliter (pg/ml).
AUC(0-48) of Dihydroergotamine After MAP0004 and IV DHE Administration in Smokers and Non-smokers
时间窗: 48 hours
The AUC(0-48) is the area under the plot of plasma concentration of drug against time after drug administration. Dihydroergotamine AUC(0-48) is reported in picograms times hour per milliliter (pg\*h/ml).
次要结局
未报告次要终点