Overview
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Status:
Completed
Completed
Trial end date:
2016-05-01
2016-05-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Acorda TherapeuticsTreatments:
Carbidopa
Levodopa
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.