Back to resultsA Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CVT-301 (Dose Level 1)
CVT-301 (Dose Level 2)
Sinemet®
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Episodic motor fluctuations (OFF periods)
Eligibility Criteria
Inclusion Criteria:
- In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
- FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
- Body Mass Index (BMI) between 18 - 30 kg/m2
Exclusion Criteria:
- No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- Negative drug and alcohol testing;
- Negative pregnancy test for female subjects
Sites / Locations
- Site #001
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CVT-301
Arm Description
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)
Outcomes
Primary Outcome Measures
Maximum observed plasma drug concentration (Cmax)
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
Secondary Outcome Measures
Number of subjects with Adverse Events (AEs) including Serious AEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02812394
Brief Title
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Official Title
A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acorda Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Episodic motor fluctuations (OFF periods)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CVT-301
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
CVT-301 (Dose Level 1)
Intervention Description
All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.
Intervention Type
Drug
Intervention Name(s)
CVT-301 (Dose Level 2)
Intervention Description
All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.
Intervention Type
Drug
Intervention Name(s)
Sinemet®
Other Intervention Name(s)
carbidopa/levodopa
Intervention Description
All subjects will receive carbidopa/levodopa tablets administered every 8 hours.
Primary Outcome Measure Information:
Title
Maximum observed plasma drug concentration (Cmax)
Time Frame
within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Title
Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)
Time Frame
within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
Secondary Outcome Measure Information:
Title
Number of subjects with Adverse Events (AEs) including Serious AEs
Time Frame
up to 9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
Body Mass Index (BMI) between 18 - 30 kg/m2
Exclusion Criteria:
No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
Negative drug and alcohol testing;
Negative pregnancy test for female subjects
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
Site #001
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets
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