A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

Completed · Phase 1

Conditions studied: Parkinson Disease

In brief

This study will be an open-label, randomized, three-period cross-over pharmacokinetic evaluation of CVT-301 compared with the Reference Listed Drug (RLD), orally administered carbidopa/levodopa, in healthy volunteers.

Key facts

Study ID

NCT02812394

Run by

Acorda Therapeutics

People needed

24

Starts

2016-06-01

Expected to finish

2016-09-01

Last updated by the study team

2016-10-26

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In good general health as determined by medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluation;
• FEV1/FVC above the 5th percentile of the predicted normal distribution for age and gender;
• Body Mass Index (BMI) between 18 - 30 kg/m2

You may not qualify if…

• No flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit;
• Negative drug and alcohol testing;
• Negative pregnancy test for female subjects

Where it is running

• Site #001 — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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