A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
Completed · Phase 1
Conditions studied: Smoking
In brief
This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.
Key facts
- Study ID
- NCT02633839
- Run by
- Acorda Therapeutics
- People needed
- 60
- Starts
- 2015-12-01
- Expected to finish
- 2016-06-01
- Last updated by the study team
- 2016-07-14
Who can join
Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Body mass index (BMI) 18 to 32 kg/m2;
- Forced expiratory volume in one second (FEV1) ≥80% of predicted for race, age, sex, and height;
- FEV1/FVC (forced vital capacity) ratio ≥70%;
- Smokers are defined as those currently smoking at least 10 cigarettes/day for at least 12 months with a positive urinary cotinine result and with no past (within 5 years) or present history of intrinsic lung disease (e.g. asthma, chronic obstructive pulmonary disease [COPD], chronic bronchitis, or other relevant conditions);
- Non-smokers are defined as those who never smoked or were exposed to less than 1 pack year within at least 12 months and with a negative urinary cotinine result.
You may not qualify if…
- Subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and who does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product;
- Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
- 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;
- History of syncope within the last 6 months.
Where it is running
- Site 001 — Daytona Beach, Florida, United States
- Site 002 — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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