Clinical trial NCT02633007: A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Lead sponsor: Acorda Therapeutics
Sponsor class: INDUSTRY
First posted: 2015-12-17
Enrollment: 25
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in pulmonary function
timeFrame: within 90 min prior to dose administration and specified time points up to 24 hours after first inhalation
Secondary outcomes:
measure: Number of subjects with Adverse Events (AEs) including Serious AEs
timeFrame: up to 12 days
measure: Maximum observed plasma drug concentration (Cmax)
timeFrame: within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose
measure: Time to maximum observed plasma drug concentration (Tmax)
timeFrame: within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose
measure: Area under the concentration time curve over the dosing interval (AUC0-last)
timeFrame: within 30 min prior to first CVT-301 dose administration and specified time points up to 24 hours post-dose
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Site 002
state: Florida
city: North Dartmouth
country: United States
facility: Site 001
state: Massachusetts
city: Dallas
country: United States
facility: Site 003
state: Texas
Study officials:
affiliation: Acorda Therapeutics
name: Harald Murck, MD, PhD
role: STUDY_DIRECTOR
References: