Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CVT-301 Single inhaled dose of CVT-301 84 mg |
Drug: CVT-301
Levodopa Inhalation Powder
|
| Active Comparator: Sinemet Single oral dose of Carbidopa/Levodopa 25 mg/100 mg |
Drug: Sinemet
Single oral dose of Carbidopa/Levodopa 25 mg/100 mg
|
Outcome Measures
Primary Outcome Measures
- 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. [4 days, 3 nights]
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.
- 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. [4 days, 3 nights]
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.
- 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. [4 days, 3 nights]
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.
- 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. [4 days, 3 nights]
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.
Secondary Outcome Measures
- Columbia-Suicide Severity Rating Scale (C-SSRS). [4 days, 3 nights]
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.
- Incidence of adverse events. [4 days, 3 nights]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women between the ages of 30 and 85 years, inclusive.
-
Have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
-
Classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
-
Stable on other non levodopa PD medications for at least 4 weeks prior to the Screening Visit.
-
Subjects must have normal cognition as confirmed by a score of ≥ 25 on the Mini Mental State Examination (MMSE), performed in the ON state.
-
Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%.
-
Body Mass Index (BMI) between 18 - 32 kg/m2, inclusive.
Exclusion Criteria:
-
Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit.
-
Chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years.
-
History of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma.
-
Narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening.
-
Previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation).
-
Current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the Screening Visit, or expected use during the study.
-
Marijuana smoking within 4 weeks prior to the Screening Visit, or expected smoking/inhalation during the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acorda Site #1003 | Long Beach | California | United States | 90806 |
| 2 | Acorda Site #1005 | Hallandale Beach | Florida | United States | 33009 |
| 3 | Acorda Site #1002 | Orlando | Florida | United States | 32806 |
| 4 | Acorda Site #1004 | Atlanta | Georgia | United States | 30331 |
| 5 | Acorda Site #1001 | Farmington Hills | Michigan | United States | 48334 |
Sponsors and Collaborators
- Acorda Therapeutics
Investigators
- Study Director: Charles Oh, MD, Acorda Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CVT-301-012