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A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CVT-301 (levodopa inhalation powder)
Carbidopa
Placebo
Sponsored by
Acorda Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma;
  • On a stable regimen of asthma medications for at least 30 days prior to screening;
  • Body mass index (BMI) 18 to 32 kg/m2;
  • Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height;
  • FEV1/FVC (forced vital capacity) ratio ≥70%.

Exclusion Criteria:

  • More than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness;
  • Asthma exacerbation within 8 weeks before screening;
  • Unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening;
  • History of intubation or intensive care unit admission for asthma in the past 5 years;
  • 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.

Sites / Locations

  • Site 002
  • Site 001
  • Site 003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

CVT-301 then Placebo (AB)

Placebo then CVT-301 (BA)

Arm Description

All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.

All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.

Outcomes

Primary 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)

Secondary Outcome Measures

Number of subjects with Adverse Events (AEs) including Serious AEs
Maximum observed plasma drug concentration (Cmax)
Time to maximum observed plasma drug concentration (Tmax)
Area under the concentration time curve over the dosing interval (AUC0-last)

Full Information

First Posted
December 11, 2015
Last Updated
June 10, 2016
Sponsor
Acorda Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02633007
Brief Title
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Official Title
A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
May 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 is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CVT-301 then Placebo (AB)
Arm Type
Experimental
Arm Description
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
Arm Title
Placebo then CVT-301 (BA)
Arm Type
Experimental
Arm Description
All subjects will receive both CVT-301 and placebo in two dosing periods separated by one day. Subjects will be randomized 1:1 into sequence AB or BA [CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)] and they will start pre-treatment of carbidopa (as Lodosyn®) administered every 8 hours until the completion of all study treatments.
Intervention Type
Drug
Intervention Name(s)
CVT-301 (levodopa inhalation powder)
Intervention Description
Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
Intervention Type
Drug
Intervention Name(s)
Carbidopa
Other Intervention Name(s)
Lodosyn ®
Intervention Description
Administered orally according to the carbidopa dosing schedule.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
Primary 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 dose administration and specified time points up to 24 hours after first inhalation
Secondary Outcome Measure Information:
Title
Number of subjects with Adverse Events (AEs) including Serious AEs
Time Frame
up to 12 days
Title
Maximum observed plasma drug concentration (Cmax)
Time Frame
within 30 min prior to first 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 first CVT-301 dose administration and specified time points up to 24 hours post-dose
Title
Area under the concentration time curve over the dosing interval (AUC0-last)
Time Frame
within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose

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: Eligible subjects will be men or women in good general health with a diagnosis of mild or moderate asthma; On a stable regimen of asthma medications for at least 30 days prior to screening; Body mass index (BMI) 18 to 32 kg/m2; Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height; FEV1/FVC (forced vital capacity) ratio ≥70%. Exclusion Criteria: More than 2 hospitalizations or emergency room visits, or more than 3 courses of systemic steroids in the past 12 months or 1 course within the past 8 weeks for respiratory illness; Asthma exacerbation within 8 weeks before screening; Unscheduled or urgent visit to any medical facility for asthma-related problems within 8 weeks before screening; History of intubation or intensive care unit admission for asthma in the past 5 years; 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.
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 002
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Site 001
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Site 003
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 Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

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