A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Change in measure of pulmonary function via Spirometry
研究概览
简要总结
This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.
详细描述
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •eligible subjects will be men or women aged 18 to 65 years inclusive;
- •body mass index (BMI) 18 to 30 kg/m2;
- •healthy adults must be in general good health with no clinically significant abnormalities that would affect ability to complete study.
- •subjects with asthma must be non-smokers who have a forced expiratory volume in one second (FEV1) ≥ 60% of predicted for race, age, sex, and height;
- •subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day history or the equivalent consumption of cigars and a positive result for plasma cotinine.
排除标准
- •subjects with asthma will be excluded for more than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
- •asthma exacerbation within 8 weeks of before screening;
- •unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
- •history of intubation or intensive care unit admission for asthma in the past 5 years.
- •Subjects who smoke will be excluded if they have intrinsic lung disease including asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);
- •any cardiovascular risk factor or contraindication for the use of triptans
- •use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors (SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or planned use during the study;
- •positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus [HCV] antibody, human immunodeficiency virus [HIV] 1 & 2 antibodies).
研究组 & 干预措施
Adult Asthmatics
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics
干预措施: CVT-427 (zolmitriptan inhalation powder) (Drug)
Adult Smokers
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers.
干预措施: CVT-427 (zolmitriptan inhalation powder) (Drug)
Adult Healthy Volunteers
Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers.
干预措施: CVT-427 (zolmitriptan inhalation powder) (Drug)
结局指标
主要结局
Change in measure of pulmonary function via Spirometry
时间窗: within 1 hour prior to dose and up to 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax)
时间窗: up to 24 hours post-dose.
Area under the concentration time curve over the dosing interval (AUC0-last)
时间窗: up to 24 hours post-dose.
Maximum observed plasma drug concentration (tmax)
时间窗: up to 24 hours post-dose.
次要结局
- Number of subjects with Adverse Events (AEs) including Serious AEs(up to 5 days)