A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Change in pulmonary function
研究概览
简要总结
This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma;
- •On a stable regimen of asthma medications for at least 30 days prior to screening;
- •Body mass index (BMI) 18 to 32 kg/m2;
- •Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height;
- •FEV1/FVC (forced vital capacity) ratio ≥70%.
排除标准
- •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 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;
- •History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
- •Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute.
研究组 & 干预措施
CVT-301 then Placebo (AB)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: CVT-301 (levodopa inhalation powder) (Drug)
CVT-301 then Placebo (AB)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: Carbidopa (Drug)
CVT-301 then Placebo (AB)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: Placebo (Other)
Placebo then CVT-301 (BA)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: CVT-301 (levodopa inhalation powder) (Drug)
Placebo then CVT-301 (BA)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: Carbidopa (Drug)
Placebo then CVT-301 (BA)
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
干预措施: Placebo (Other)
结局指标
主要结局
Change in pulmonary function
时间窗: within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation
Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
次要结局
- Number of subjects with Adverse Events (AEs) including Serious AEs(up to 12 days)
- Maximum observed plasma drug concentration (Cmax)(within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose)
- Time to maximum observed plasma drug concentration (Tmax)(within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose)
- Area under the concentration time curve over the dosing interval (AUC0-last)(within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose)