A Phase 1 Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Maximum observed plasma drug concentration (Cmax)
研究概览
简要总结
This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
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
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index (BMI) 18 to 32 kg/m2;
- •Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
- •FEV1/FVC (forced vital capacity) ratio ≥70%;
- •Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions);
- •Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.
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 flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- •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;
- •History of syncope within the last 6 months.
研究组 & 干预措施
Adults who smoke
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
干预措施: CVT-301 (Drug)
Adults who smoke
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
干预措施: Carbidopa (Drug)
Adults who don't smoke
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
干预措施: CVT-301 (Drug)
Adults who don't smoke
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
干预措施: Carbidopa (Drug)
结局指标
主要结局
Maximum observed plasma drug concentration (Cmax)
时间窗: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (tmax)
时间窗: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Area under the plasma concentration versus time curve (AUC)
时间窗: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
次要结局
- Number of subjects with Adverse Events (AEs) including Serious AEs(up to 3 days)
- Change in pulmonary function(within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose)