A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
- Registration Number
- NCT02633839
- Lead Sponsor
- Acorda Therapeutics
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adults who don't smoke CVT-301 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. Adults who smoke CVT-301 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. Adults who smoke Carbidopa 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. Adults who don't smoke Carbidopa 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.
- Primary Outcome Measures
Name Time Method Maximum observed plasma drug concentration (Cmax) 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) 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) within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
- Secondary Outcome Measures
Name Time Method 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 Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Trial Locations
- Locations (2)
Site 001
🇺🇸Daytona Beach, Florida, United States
Site 002
🇺🇸Dallas, Texas, United States