A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

• CVT-301 (levodopa inhalation powder) (Drug): Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
• Carbidopa (Drug), also known as Lodosyn ®: Administered orally according to the carbidopa dosing schedule.
• Placebo (Other): Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.

Primary outcomes

• Change in pulmonary function [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)

Secondary outcomes

• 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]

Sex: All, ages: 25 Years to 65 Years

Inclusion Criteria:

* 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%.

Exclusion Criteria:

* 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.

• Harald Murck, MD, PhD, Study director, Acorda Therapeutics