A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
Phase 1
Completed
- Conditions
- Migraine
- Interventions
- Drug: CVT-427 (zolmitriptan inhalation powder)
- Registration Number
- NCT02905227
- Lead Sponsor
- Acorda Therapeutics
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adult Asthmatics CVT-427 (zolmitriptan inhalation powder) Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics Adult Smokers CVT-427 (zolmitriptan inhalation powder) Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers. Adult Healthy Volunteers CVT-427 (zolmitriptan inhalation powder) Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers.
- Primary Outcome Measures
Name Time Method 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. Area under the concentration time curve over the dosing interval (AUC0-last) up to 24 hours post-dose. Maximum observed plasma drug concentration (tmax) up to 24 hours post-dose.
- Secondary Outcome Measures
Name Time Method Number of subjects with Adverse Events (AEs) including Serious AEs up to 5 days
Trial Locations
- Locations (3)
Site #102
🇺🇸Lincoln, Nebraska, United States
Site #103
🇺🇸North Dartmouth, Massachusetts, United States
Site #101
🇺🇸Dallas, Texas, United States