A Phase 1 First in Human Open-Label Study of the Safety and Pharmacokinetics of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Number of patients with adverse events (AEs) including serious AEs
研究概览
简要总结
This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in adult healthy volunteers.
详细描述
Objectives:
- To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427 (zolmitriptan inhalation powder) in healthy adults, with special emphasis on cardiopulmonary effects.
- To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig® Tablet, and Zomig® Nasal Spray in healthy adults.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult men or women volunteers aged 18 to 65 years, inclusive;
- •Triptan-naïve;
- •Body mass index (BMI) between 18 to 30 kg/m2;
- •Forced expiratory volume in one second (FEV1) greater than 80% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio greater than or equal to 70%;
- •No history of asthma;
- •Non-smoking for at least 5 years;
- •In good general health with no clinically significant abnormalities or recognized cardiovascular risk factors that preclude use of triptans and that would interfere with participation in this study as determined by medical history, physical examination, electrocardiogram, and clinical laboratory test results; and negative tests for drug and alcohol, serology, and for pregnancy for female subjects of childbearing potential.
排除标准
- •Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
- •Any cardiovascular risk factor including clinically relevant ECG parameter (e.g., PR interval, QRS deviation) or other clinically significant ECG abnormality;
- •History of asthma (including exercise-induced asthma and cold-induced asthma) or chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
- •Any flu-like syndrome or other respiratory infections within 4 weeks of CVT-427 administration;
- •Unable to tolerate blood draws.
研究组 & 干预措施
CVT-427 (zolmitriptan inhalation powder)
Periods 1-2: Subjects will receive Zomig oral tablet in Period 1 and Zomig nasal spray in Period 2, 1 hour apart.
Periods 3-6: Subjects will receive CVT-427 (dose levels (DL) 1, 2, 3 and 4), administered in ascending order provided that safety and tolerability data are observed to be adequate to allow dose escalation, approximately 24 hours after preceding DL.
干预措施: zolmitriptan (Drug)
CVT-427 (zolmitriptan inhalation powder)
Periods 1-2: Subjects will receive Zomig oral tablet in Period 1 and Zomig nasal spray in Period 2, 1 hour apart.
Periods 3-6: Subjects will receive CVT-427 (dose levels (DL) 1, 2, 3 and 4), administered in ascending order provided that safety and tolerability data are observed to be adequate to allow dose escalation, approximately 24 hours after preceding DL.
干预措施: CVT-427 (zolmitriptan inhalation powder), (Drug)
结局指标
主要结局
Number of patients with adverse events (AEs) including serious AEs
时间窗: up to 23 days
Pulmonary function
时间窗: within 90 min prior to dosing and at specified time points up to 24 hours post-dose
Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Maximum observed plasma drug concentration (Cmax)
时间窗: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax)
时间窗: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Area under the concentration time curve (AUC)
时间窗: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Terminal elimination half-life (t½)
时间窗: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
次要结局
未报告次要终点