A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

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.