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

NCT02633007 | Completed Phase 1

• 1 other identifier: CVT-301-008
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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)

  within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation

Secondary Outcomes (4)

• Number of subjects with Adverse Events (AEs) including Serious AEs

  up to 12 days

• 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

• 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

• 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

Study Arms (2)

CVT-301 then Placebo (AB)

EXPERIMENTAL

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); Drug: Carbidopa; Other: Placebo

Placebo then CVT-301 (BA)

EXPERIMENTAL

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); Drug: Carbidopa; Other: Placebo

Interventions

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.

CVT-301 then Placebo (AB); Placebo then CVT-301 (BA)

Carbidopa DRUG

Administered orally according to the carbidopa dosing schedule.

Also known as: Lodosyn ®

CVT-301 then Placebo (AB); Placebo then CVT-301 (BA)

Placebo OTHER

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

CVT-301 then Placebo (AB); Placebo then CVT-301 (BA)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Acorda Therapeutics: lead

Study Sites (3)

Site 002

Daytona Beach, Florida, 32117, United States

Location

Site 001

North Dartmouth, Massachusetts, 02747, United States

Location

Site 003

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Carbidopa

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyldopa; Dihydroxyphenylalanine; Catecholamines; Amines; Organic Chemicals; Hydrazines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Harald Murck, MD, PhD

  Acorda Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: May 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

US (3)