This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
Site #103
North Dartmouth, Massachusetts, United States
Site #102
Lincoln, Nebraska, United States
Site #101
Dallas, Texas, United States
Change in measure of pulmonary function via Spirometry
Time frame: within 1 hour prior to dose and up to 24 hours post-dose.
Maximum observed plasma drug concentration (Cmax)
Time frame: up to 24 hours post-dose.
Maximum observed plasma drug concentration (tmax)
Time frame: up to 24 hours post-dose.
Area under the concentration time curve over the dosing interval (AUC0-last)
Time frame: up to 24 hours post-dose.
Number of subjects with Adverse Events (AEs) including Serious AEs
Time frame: up to 5 days
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