A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
研究概览
简要总结
Compare the DHE pharmacokinetic profiles observed following administration of:
- MAP0004 (oral inhalation DHE)
- MAP0004 co-administered with oral Ketoconazole
- Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)
Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •History of hemiplegic or basilar migraine
- •Participation in another investigational trial during the 12 weeks prior to Visit 1 or during this trial
研究组 & 干预措施
All subjects
Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).
干预措施: MAP0004 (Drug)
All subjects
Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).
干预措施: IV DHE (Drug)
All subjects
Subjects received MAP0004 on Day 1 of Visit 2, Ketoconazole on Days 3 through 6 of Visit 2, and MAP0004 again on Day 6 of Visit 2. Subjects then returned for Visit 3, 7-11 days from the end of Visit 2. At Visit 3 subjects received 1.0 mg IV DHE (Intravenous Dihydroergotamine Mesylate).
干预措施: Ketoconazole (Drug)
结局指标
主要结局
Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
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, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
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