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Completed

NCT Number: NCT02633007

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site 002, Daytona Beach, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVT-301 (levodopa inhalation powder)

Drug

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.

Carbidopa

Drug

Administered orally according to the carbidopa dosing schedule.

Other names: Lodosyn ®

Placebo

Other

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

Primary outcomes

  1. Change in pulmonary function

    Time frame: 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 outcomes

  1. Number of subjects with Adverse Events (AEs) including Serious AEs

    Time frame: up to 12 days

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 17, 2015
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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