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Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CVT-301

Sinemet

About this trial

This is an interventional other trial for Parkinson's Disease

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Acorda Site #1003
Acorda Site #1005
Acorda Site #1002
Acorda Site #1004
Acorda Site #1001

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CVT-301

Sinemet

Arm Description

Single inhaled dose of CVT-301 84 mg

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Outcomes

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.

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.

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.

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.

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).

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.

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.

Full Information

NCT ID

NCT03887884

First Posted

March 1, 2019

Last Updated

August 1, 2019

Sponsor

Acorda Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT03887884

Brief Title

Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

March 5, 2019 (Actual)

Primary Completion Date

June 28, 2019 (Actual)

Study Completion Date

June 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acorda Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CVT-301

Arm Type

Experimental

Arm Description

Single inhaled dose of CVT-301 84 mg

Arm Title

Sinemet

Arm Type

Active Comparator

Arm Description

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Intervention Type

Drug

Intervention Name(s)

CVT-301

Intervention Description

Levodopa Inhalation Powder

Intervention Type

Drug

Intervention Name(s)

Sinemet

Intervention Description

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Primary Outcome Measure Information:

Title

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.

Description

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.

Time Frame

4 days, 3 nights

Title

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.

Description

Time Frame

4 days, 3 nights

Title

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.

Description

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 Frame

4 days, 3 nights

Title

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.

Description

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.

Time Frame

4 days, 3 nights

Secondary Outcome Measure Information:

Title

Columbia-Suicide Severity Rating Scale (C-SSRS).

Description

Time Frame

4 days, 3 nights

Title

Incidence of adverse events.

Description

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.

Time Frame

4 days, 3 nights

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Charles Oh, MD

Organizational Affiliation

Acorda Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Acorda Site #1003

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Acorda Site #1005

City

Hallandale Beach

State/Province

Florida

ZIP/Postal Code

33009

Country

United States

Facility Name

Acorda Site #1002

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Acorda Site #1004

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Acorda Site #1001

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48334

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32482490

Citation

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.

Results Reference

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Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

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