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, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.
The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center.
On each of two treatment days, subjects will consume a standard high fat meal and then receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such that each subject receives both Treatment A and Treatment B over the 2 treatment days, randomized 1:1 to the treatment sequence AB or BA.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CVT-301 | Experimental | Single inhaled dose of CVT-301 84 mg |
|
| Sinemet | Active Comparator | Single oral dose of Carbidopa/Levodopa 25 mg/100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CVT-301 | Drug | Levodopa Inhalation Powder |
| |
| Sinemet |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease. | Maximum observed plasma drug concentration (Cmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state. | 4 days, 3 nights |
| Total plasma concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease. | Area under the plasma concentration curve from time 0 to the concentration at 4 hours (AUCo-4h) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state. | 4 days, 3 nights |
| Terminal half-life of a single inhaled dose of CVT-30184 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease. | Terminal half-life (t1/2)of a single inhaled dose of CVT-30184 and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state. | 4 days, 3 nights |
| Time to maximum observed plasma drug concentration of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg (carbidopa/levodopa) in patients with Parkinson's disease. | Time to maximum observed plasma drug concentration (Tmax) of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25 mg/100 mg in patients with Parkinson's disease (PD) in a fed state. | 4 days, 3 nights |
| Measure | Description | Time Frame |
|---|---|---|
| Columbia-Suicide Severity Rating Scale (C-SSRS). | To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients using the Columbia-Suicide Severity Rating Scale (C-SSRS). The (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes. Subscales not applicable. |
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 |
|---|---|---|---|---|---|---|
| Acorda Site #1003 | Long Beach | California | 90806 | United States | ||
| Acorda Site #1005 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32482490 | Derived | Safirstein BE, Ellenbogen A, Zhao P, Henney HR 3rd, Kegler-Ebo DM, Oh C. Pharmacokinetics of Inhaled Levodopa Administered With Oral Carbidopa in the Fed State in Patients With Parkinson's Disease. Clin Ther. 2020 Jun;42(6):1034-1046. doi: 10.1016/j.clinthera.2020.04.004. Epub 2020 May 29. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C009265 | carbidopa, levodopa drug combination |
Not provided
Not provided
Not provided
It is a 2-way crossover Pharmacokinetic (PK) evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of Carbidopa/levodopa (CD/LD) 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease patients who regularly take CD/LD.
Not provided
Not provided
Not provided
Not provided
| Drug |
Single oral dose of Carbidopa/Levodopa 25 mg/100 mg |
|
| 4 days, 3 nights |
| Incidence of adverse events. | To evaluate the safety and tolerability of a single inhaled dose of CVT-301 84 mg and an oral dose of CD/LD 25/100 mg) under fed conditions in PD patients by accessing adverse events. | 4 days, 3 nights |
| Hallandale |
| Florida |
| 33009 |
| United States |
| Acorda Site #1002 | Orlando | Florida | 32806 | United States |
| Acorda Site #1004 | Atlanta | Georgia | 30331 | United States |
| Acorda Site #1001 | Farmington Hills | Michigan | 48334 | United States |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |