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

NCT ID: NCT02633007

Last Updated: 2016-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-05-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

CVT-301 (levodopa inhalation powder)

Intervention Type: 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

Intervention Type: DRUG

Administered orally according to the carbidopa dosing schedule.

Placebo

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

CVT-301 (levodopa inhalation powder)

Intervention Type: 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

Intervention Type: DRUG

Administered orally according to the carbidopa dosing schedule.

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Carbidopa

Administered orally according to the carbidopa dosing schedule.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Lodosyn ®

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acorda Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Harald Murck, MD, PhD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

Site 002

Daytona Beach, Florida, United States

Site 001

North Dartmouth, Massachusetts, United States

Site 003

Dallas, Texas, United States

Countries

United States

Other Identifiers

CVT-301-008

Identifier Type: -

Identifier Source: org_study_id