A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427
zolmitriptan inhalation powder in the study populations.

Inclusion Criteria:

- eligible subjects will be men or women aged 18 to 65 years inclusive;

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

- healthy adults must be in general good health with no clinically significant
abnormalities that would affect ability to complete study.

- subjects with asthma must be non-smokers who have a forced expiratory volume in one
second (FEV1) ≥ 60% of predicted for race, age, sex, and height;

- subjects who smoke must have at least a 12-month, 0.5 pack of cigarettes per day
history or the equivalent consumption of cigars and a positive result for plasma
cotinine.

Exclusion Criteria:

- subjects with asthma will be excluded for 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 of 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.

- Subjects who smoke will be excluded if they have intrinsic lung disease including
asthma or chronic obstructive pulmonary disease (COPD) with an FEV1 of <60% of
predicted and a score of ≥2 on the Medical Research Council Dsypnea Scale (MRC);

- any cardiovascular risk factor or contraindication for the use of triptans

- use of nonselective monamine oxidase inhibitors (MAOI), serotonin reuptake inhibitors
(SSRIs), propranolol, or cimetidine within 4 weeks prior to the Screening Visit, or
planned use during the study;

- positive serology test (hepatitis B virus surface antigen [HBsAg], hepatitis C virus
[HCV] antibody, human immunodeficiency virus [HIV] 1 & 2 antibodies).