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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.
The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Asthmatics | Experimental | 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 | Experimental | 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 | Experimental | Two doses of CVT-427, 2 hours apart. 3.0 mg zolmitriptan capsule administered via CVT-427 breath-actuated inhaler in adult healthy volunteers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-427 (zolmitriptan inhalation powder) | Drug | Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart. |
|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events (AEs) including Serious AEs | up to 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Oh, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #103 | North Dartmouth | Massachusetts | 02747 | United States | ||
| Site #102 |
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| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| Lincoln |
| Nebraska |
| 68502 |
| United States |
| Site #101 | Dallas | Texas | 75247 | United States |
| D009422 | Nervous System Diseases |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |