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



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:25 - 65
Updated:4/21/2016
Start Date:December 2015
End Date:May 2016

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A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

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.


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.
We found this trial at
3
sites
North Dartmouth, Massachusetts 02747
Phone: 508-992-7595
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Dallas, Texas 75390
Phone: 469-513-6667
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Daytona Beach, Florida 32117
Phone: 386-366-6418
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