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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

Sponsor
Acorda Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02633007
Collaborator
(none)
25
Enrollment
3
Locations
2
Arms
5
Duration (Months)
8.3
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CVT-301 (levodopa inhalation powder)
  • Drug: Carbidopa
  • Other: Placebo
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: CVT-301 then Placebo (AB)

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.

Drug: CVT-301 (levodopa inhalation powder)
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.

Drug: Carbidopa
Administered orally according to the carbidopa dosing schedule.
Other Names:
  • Lodosyn ®

    • Other: Placebo
    Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
    Experimental: Placebo then CVT-301 (BA)

    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.

    Drug: CVT-301 (levodopa inhalation powder)
    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.

    Drug: Carbidopa
    Administered orally according to the carbidopa dosing schedule.
    Other Names:
  • Lodosyn ®

    • Other: Placebo
    Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.

    Outcome Measures

    Primary Outcome Measures

    1. Change in pulmonary function [within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation]

      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

    1. Number of subjects with Adverse Events (AEs) including Serious AEs [up to 12 days]

    2. Maximum observed plasma drug concentration (Cmax) [within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose]

    3. Time to maximum observed plasma drug concentration (Tmax) [within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose]

    4. Area under the concentration time curve over the dosing interval (AUC0-last) [within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 002 Daytona Beach Florida United States 32117
    2 Site 001 North Dartmouth Massachusetts United States 02747
    3 Site 003 Dallas Texas United States 75247

    Sponsors and Collaborators

    • Acorda Therapeutics

    Investigators

    • Study Director: Harald Murck, MD, PhD, Acorda Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Acorda Therapeutics
    ClinicalTrials.gov Identifier:
    NCT02633007
    Other Study ID Numbers:
    • CVT-301-008
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Jun 13, 2016
    Last Verified:
    Jun 1, 2016
    Additional relevant MeSH terms:
    Asthma
    Levodopa
    Carbidopa

    Study Results

    No Results Posted as of Jun 13, 2016