Back to resultsA Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
Primary Purpose
Smoking
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CVT-301
Carbidopa
Sponsored by
About this trial
This is an interventional treatment trial for Smoking focused on measuring Adults
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) 18 to 32 kg/m2;
- Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
- FEV1/FVC (forced vital capacity) ratio ≥70%;
- Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions);
- Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.
Exclusion Criteria:
- Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
- Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
- Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute;
- History of syncope within the last 6 months.
Sites / Locations
- Site 001
- Site 002
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Adults who smoke
Adults who don't smoke
Arm Description
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours. Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
Outcomes
Primary Outcome Measures
Maximum observed plasma drug concentration (Cmax)
Time to maximum observed plasma drug concentration (tmax)
Area under the plasma concentration versus time curve (AUC)
Secondary Outcome Measures
Change in pulmonary function
Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Number of subjects with Adverse Events (AEs) including Serious AEs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02633839
Brief Title
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
Official Title
A Phase 1 Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
June 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 is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking
Keywords
Adults
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adults who smoke
Arm Type
Experimental
Arm Description
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
Arm Title
Adults who don't smoke
Arm Type
Experimental
Arm Description
Day -1, subjects begin pre-treatment of oral dose regimen of carbidopa every 8 hours.
Day 1, subjects receive a final dose of carbidopa and 1 hour later, a single dose of CVT-301.
Intervention Type
Drug
Intervention Name(s)
CVT-301
Intervention Description
Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.
Intervention Type
Drug
Intervention Name(s)
Carbidopa
Other Intervention Name(s)
Lodosyn ®
Intervention Description
Administered orally according to the carbidopa dosing schedule.
Primary Outcome Measure Information:
Title
Maximum observed plasma drug concentration (Cmax)
Time Frame
within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Title
Time to maximum observed plasma drug concentration (tmax)
Time Frame
within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Title
Area under the plasma concentration versus time curve (AUC)
Time Frame
within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose
Secondary Outcome Measure Information:
Title
Change in pulmonary function
Description
Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)
Time Frame
within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose
Title
Number of subjects with Adverse Events (AEs) including Serious AEs
Time Frame
up to 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) 18 to 32 kg/m2;
Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
FEV1/FVC (forced vital capacity) ratio ≥70%;
Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions);
Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.
Exclusion Criteria:
Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
History of chronic obstructive pulmonary disorder (COPD) requiring intermittent or continuous use of any oral or inhaled medication therapy within last 3 years;
Renal impairment as defined by a calculated creatinine clearance of ≤ 80 mL/minute;
History of syncope within the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harald Murck, MD, PhD
Organizational Affiliation
Acorda Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Site 001
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site 002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
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