This study is the first study in humans with CVT-427 (zolmitriptan inhalation powder) and is designed to evaluate the safety, tolerability, and PK of single ascending doses of CVT-427 in adult healthy volunteers.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Oral Tablet and Nasal Spray
Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
Site 001
Daytona Beach, Florida, United States
Site 002
Dallas, Texas, United States
Number of patients with adverse events (AEs) including serious AEs
Time frame: up to 23 days
Pulmonary function
Measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Time frame: within 90 min prior to dosing and at specified time points up to 24 hours post-dose
Maximum observed plasma drug concentration (Cmax)
Time frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (Tmax)
Time frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Area under the concentration time curve (AUC)
Time frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
Terminal elimination half-life (t½)
Time frame: within 15 minutes pre-dose and at specified time points up to 24 hours post-dose
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