Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.
The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 | Experimental | CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 (Dose Level 1) | Drug | All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma drug concentration (Cmax) | within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. | |
| Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h) | within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse Events (AEs) including Serious AEs | up to 9 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles Oh, MD | Acorda Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site #001 | Dallas | Texas | 75247 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| CVT-301 (Dose Level 2) | Drug | All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses. |
|
| Sinemet® | Drug | All subjects will receive carbidopa/levodopa tablets administered every 8 hours. |
|
|
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
Not provided
Not provided
Not provided