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This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 then Placebo (AB) | Experimental | All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments. |
|
| Placebo then CVT-301 (BA) | Experimental | All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 (levodopa inhalation powder) | Drug | Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events (AEs) including Serious AEs | up to 12 days | |
| Maximum observed plasma drug concentration (Cmax) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Harald Murck, MD, PhD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 002 | Daytona Beach | Florida | 32117 | United States | ||
| Site 001 |
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| Carbidopa | Drug | Administered orally according to the carbidopa dosing schedule. |
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| Placebo | Other | Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa. |
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| Time to maximum observed plasma drug concentration (Tmax) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
| Area under the concentration time curve over the dosing interval (AUC0-last) | within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose |
| North Dartmouth |
| Massachusetts |
| 02747 |
| United States |
| Site 003 | Dallas | Texas | 75247 | United States |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| D002230 | Carbidopa |
| ID | Term |
|---|---|
| D008750 | Methyldopa |
| D004295 | Dihydroxyphenylalanine |
| D002395 | Catecholamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006834 | Hydrazines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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