Migraine
Conditions
Keywords
Adult smokers, Asthma, Healthy volunteers
Brief summary
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.
Detailed description
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
Interventions
DRUGCVT-427 (zolmitriptan inhalation powder)
Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
Sponsors
Acorda Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in measure of pulmonary function via Spirometry | within 1 hour prior to dose and up to 24 hours post-dose. |
| Maximum observed plasma drug concentration (Cmax) | up to 24 hours post-dose. |
| Maximum observed plasma drug concentration (tmax) | up to 24 hours post-dose. |
| Area under the concentration time curve over the dosing interval (AUC0-last) | up to 24 hours post-dose. |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects with Adverse Events (AEs) including Serious AEs | up to 5 days |
Countries
United States
Outcome results
None listed