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

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: CVT-301 (levodopa inhalation powder); Drug: Carbidopa; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02633007

CVT-301-008

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

CVT-301 then Placebo (AB)

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: CVT-301 (levodopa inhalation powder)

Drug: Carbidopa

Placebo then CVT-301 (BA)

Experimental group

Description:

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.

Treatment:

Other: Placebo

Drug: CVT-301 (levodopa inhalation powder)

Drug: Carbidopa