A Single-Center, Open-label, Single-Arm Study to Evaluate the Effects of Repeat Doses of Subcutaneously Delivered Sumatriptan Via the Intraject System of Local Injection Site Signs in Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
研究概览
简要总结
Intraject is a needle-free, single use, disposable, subcutaneous delivery system pre-filled with 6 mg sumatriptan. Healthy Individuals will be enrolled for a series of 3 injections over 2 days. Assessment of Local Site Signs will be recorded for up to 5 days, as needed.
详细描述
This study will evaluate the extent, persistence, and any cumulative effects on skin tissue by assessing local injection site reactions (bleeding, swelling, erythema, bruising) following repeated administrations of needle-free Intraject sumatriptan to the same anatomic site.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female subjects of child-bearing potential must agree to use acceptable birth control
- •Have abdominal or thigh injection sites that have sufficient subcutaneous tissue for needle-free injection
- •Fluent in the spoken and written English language
- •Provide written informed consent to participate in the study and be willing to comply with the study procedures
- •Non-tobacco user for at least 12 months prior to screening (all types of tobacco, including cigars)
排除标准
- •A history, symptoms, or signs of ischemic cardiac, cerebrovascular, or peripheral vascular syndromes including ischemic or vasospastic coronary artery disease
- •Other significant underlying cardiovascular diseases including uncontrolled hypertension
- •Hemiplegic or basilar migraine
- •A history or diagnosis of severe hepatic or renal impairment
- •A history of epilepsy or seizure or other serious neurologic condition
- •A history of allergy, anaphylaxis, or hypersensitivity to sumatriptan or any of its components or similar drugs
- •A history of scleroderma (systemic sclerosis) or any skin condition that may adversely affect the injection or absorption of subcutaneously administered medications
- •Tattoos, birthmarks or other significant skin discoloration in the thigh or abdominal area that are large enough to restrict injection site selection and/or evaluation
- •Pregnancy or breast-feeding
- •Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing
结局指标
主要结局
The Number of Injections With Local Site Reactions (Bleeding, Swelling, Bruising and Erythema).
时间窗: -15 min, immediately Post-dose, and 1, 4, 8, 24, 48 and 72 hrs post-dose
Each of the 18 participants were injected three times (for a total of 54 injections)with Sumavel DosePro, and followed over three days.
次要结局
未报告次要终点