Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Parkinson's Disease Clinical Trial

Official title:

Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887884
• Other study ID #: CVT-301-012
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2019
• Est. completion date: June 28, 2019

Study information

• Verified date: August 2019
• Source: Acorda Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• CVT-301
Levodopa Inhalation Powder
• Sinemet
Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Locations

Country	Name	City	State
United States	Acorda Site #1004	Atlanta	Georgia
United States	Acorda Site #1001	Farmington Hills	Michigan
United States	Acorda Site #1005	Hallandale Beach	Florida
United States	Acorda Site #1003	Long Beach	California
United States	Acorda Site #1002	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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.	4 days, 3 nights
Secondary	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