A Randomized, Open-Label, Crossover Study to Evaluate the PK, Bioavailability, Dose Proportionality, Safety, and Tolerability of Single Doses of STS101, DHE Mesylate IM Injection and DHE Mesylate Nasal Spray in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- STS101 Dose Selection - Part 1
研究概览
简要总结
Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part), pharmacokinetic and safety study.
详细描述
Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover manner.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 50 years of age at the time of enrollment.
- •Signed the informed consent document.
- •Subject judged to be healthy by a qualified physician
排除标准
- •Abnormal physical findings of clinical significance at the screening examination
- •Significant abnormal laboratory values at the Screening Visit.
- •Clinically significant symptoms or conditions that may have placed the subject at an unacceptable risk as a participant in the trial, or that may have interfered with the absorption, distribution, metabolism or excretion of the IMP.
研究组 & 干预措施
STS101 1.5 mg
STS101 (dihydroergotamine nasal powder), 1.5 mg
干预措施: Dihydroergotamine (Drug)
STS101 3.0 mg
STS101 (dihydroergotamine nasal powder), 3.0 mg
干预措施: Dihydroergotamine (Drug)
STS101 6.0 mg
STS101 (dihydroergotamine nasal powder), 6.0 mg
干预措施: Dihydroergotamine (Drug)
DHE intramuscular injection
Dihydroergotamine mesylate
干预措施: Dihydroergotamine (Drug)
DHE nasal spray
Dihydroergotamine mesylate
干预措施: Dihydroergotamine (Drug)
结局指标
主要结局
STS101 Dose Selection - Part 1
时间窗: Pre-dose through 48 hours post-dose
To select a dose level of STS101 for further evaluation in Part 2
DHE Relative Bioavailability - Part 2
时间窗: Pre-dose through 48 hours post-dose
To assess the relative bioavailability of dihydroergotamine following a single dose of STS101 at the dose level selected in Part 1 compared to a single dose of 1 mg DHE administered by intramuscular injection and 2 mg DHE administered as nasal spray
次要结局
- 8'OH-DHE Area Under the Curve [AUC] - Part 1(Pre-dose through 48 hours post-dose)
- Serious Adverse Events - Parts 1 & 2(Pre-dose through 48 hours post-dose)
- DHE Area Under the Curve [AUC] - Part 1(Pre-dose through 48 hours post-dose)
- Treatment-Related Adverse Events - Parts 1 & 2(Pre-dose through 48 hours post-dose)