A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

Study Overview
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Brief Summary
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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
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The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.

Official Title
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A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers

Conditions
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Migraine

Intervention / Treatment
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* Drug: CVT-427 (zolmitriptan inhalation powder)


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adult Asthmatics<br>Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult asthmatics | Drug: CVT-427 (zolmitriptan inhalation powder)<br>* Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.<br>|
| Experimental: Adult Smokers<br>Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult smokers. | Drug: CVT-427 (zolmitriptan inhalation powder)<br>* Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.<br>|
| Experimental: Adult Healthy Volunteers<br>Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers. | Drug: CVT-427 (zolmitriptan inhalation powder)<br>* Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with Adverse Events (AEs) including Serious AEs |  | up to 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adult smokers, Asthma, Healthy volunteers