Safety and Pharmacokinetics (PK) Study of Single Ascending Doses of CVT-427 (Zolmitriptan Inhalation Powder) In Healthy Adults

Objectives:

- To evaluate the overall safety and tolerability of single, inhaled doses of CVT-427
(zolmitriptan inhalation powder) in healthy adults, with special emphasis on
cardiopulmonary effects.

- To describe the pharmacokinetics (PK) of single, inhaled doses of CVT-427, Zomig®
Tablet, and Zomig® Nasal Spray in healthy adults.

Inclusion Criteria:

- Healthy adult men or women volunteers aged 18 to 65 years, inclusive;

- Triptan-naïve;

- Body mass index (BMI) between 18 to 30 kg/m2;

- Forced expiratory volume in one second (FEV1) greater than 80% of predicted for race,
age, sex, and height and FEV1/FVC (forced vital capacity) ratio greater than or equal
to 70%;

- No history of asthma;

- Non-smoking for at least 5 years;

- In good general health with no clinically significant abnormalities or recognized
cardiovascular risk factors that preclude use of triptans and that would interfere
with participation in this study as determined by medical history, physical
examination, electrocardiogram, and clinical laboratory test results; and negative
tests for drug and alcohol, serology, and for pregnancy for female subjects of
childbearing potential.

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 cardiovascular risk factor including clinically relevant ECG parameter (e.g., PR
interval, QRS deviation) or other clinically significant ECG abnormality;

- History of asthma (including exercise-induced asthma and cold-induced asthma) or
chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous
use of any oral or inhaled medication therapy within last 3 years;

- Any flu-like syndrome or other respiratory infections within 4 weeks of CVT-427
administration;

- Unable to tolerate blood draws.