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A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

Sponsor
Acorda Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02633839
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
6
Duration (Months)
30
Patients Per Site
5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adults who smoke

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.

Drug: CVT-301
Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.

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

    		•
    Experimental: Adults who don't smoke

    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.

    Drug: CVT-301
    Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    3. Area under the plasma concentration versus time curve (AUC) [within 30 min prior to CVT-301 dose administration and specified time points up to 24 hours post-dose]

    Secondary Outcome Measures

    1. Change in pulmonary function [within 90 min prior to CVT-301 dose and at specified time points up to 24 hours post-dose]

      Pulmonary function will be measured by spirometry using the guideline specified by the Third National Health and Nutrition Examination Survey (NHANES III)

    2. Number of subjects with Adverse Events (AEs) including Serious AEs [up to 3 days]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Site 001 Daytona Beach Florida United States 32117
    2 Site 002 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:
    NCT02633839
    Other Study ID Numbers:
    • CVT-301-007
    First Posted:
    Dec 17, 2015
    Last Update Posted:
    Jul 14, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by Acorda Therapeutics
    Adults
    Additional relevant MeSH terms:
    Respiratory Aspiration
    Carbidopa

    Study Results

    No Results Posted as of Jul 14, 2016