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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: CVT-301 (levodopa inhalation powder); Drug: Carbidopa; Other: Placebo

• Registration Number: NCT02633007
• Lead Sponsor: Acorda Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-11
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-17
• Primary Completion: 2016-03
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CVT-301 then Placebo (AB)	CVT-301 (levodopa inhalation powder)	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.
CVT-301 then Placebo (AB)	Placebo	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.
Placebo then CVT-301 (BA)	CVT-301 (levodopa inhalation powder)	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.
Placebo then CVT-301 (BA)	Placebo	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.
CVT-301 then Placebo (AB)	Carbidopa	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.
Placebo then CVT-301 (BA)	Carbidopa	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.

Primary Outcome Measures

Name	Time	Method
Change in pulmonary function	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Site 002; 🇺🇸 Daytona Beach, Florida, United States

Site 003; 🇺🇸 Dallas, Texas, United States

Site 001; 🇺🇸 North Dartmouth, Massachusetts, United States