This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Site 001
Daytona Beach, Florida, United States
Site 002
Dallas, Texas, United States
Maximum observed plasma drug concentration (Cmax)
Time frame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Time to maximum observed plasma drug concentration (tmax)
Time frame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Area under the plasma concentration versus time curve (AUC)
Time frame: within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Change in pulmonary function
Pulmonary function will be 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 CVT-301 dose and at specified time points up to 24 hours post-dose
Number of subjects with Adverse Events (AEs) including Serious AEs
Time frame: up to 3 days
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