Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Completed · Phase 1

Conditions studied: Parkinson's Disease

In brief

This study will be an open-label, randomized, multi-center, 2-way crossover Pharmacokinetic PK evaluation of a single inhaled dose of CVT-301 84 mg and a single oral dose of carbidopa/levodopa CD/LD 25 mg/100 mg (Sinemet®) under fed conditions in Parkinson's Disease (PD) patients who regularly take CD/LD.

Key facts

Study ID

NCT03887884

Run by

Acorda Therapeutics

People needed

23

Starts

2019-03-05

Expected to finish

2019-06-28

Last updated by the study team

2019-08-02

Who can join

Age: 30 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women between the ages of 30 and 85 years, inclusive.
• Have idiopathic PD (i.e., not induced by drugs or other diseases) as defined by fulfilling Steps 1 and 2 of the United Kingdom (UK) Brain Bank criteria, diagnosed after the age of 30 years.
• Classified as Stage 1 to 3 (in the ON state) on the modified Hoehn and Yahr scale for staging of PD severity.
• Stable on other non levodopa PD medications for at least 4 weeks prior to the Screening Visit.
• Subjects must have normal cognition as confirmed by a score of ≥ 25 on the Mini Mental State Examination (MMSE), performed in the ON state.
• Forced expiratory volume in one second (FEV1) ≥60% of predicted for race, age, sex, and height and FEV1/FVC (forced vital capacity) ratio ≥70%.
• Body Mass Index (BMI) between 18 - 32 kg/m2, inclusive.

You may not qualify if…

• Any flu-like syndrome or other respiratory infections within 2 weeks prior to the Screening Visit.
• Chronic obstructive pulmonary disease (COPD), asthma, or other chronic respiratory disease within the last 5 years.
• History of any cancer in the past 5 years with the exception of successfully treated basal cell carcinoma.
• Narrow angle glaucoma or a history of peptic ulcer disease less than 1 year prior to screening.
• Previous surgery for PD (including but not limited to deep brain stimulation or cell transplantation).
• Current use of nicotine patch or tobacco-containing products including cigarettes, electronic cigarettes, cigars, chewing tobacco, pipe tobacco or snuff or use within 4 weeks prior to the Screening Visit, or expected use during the study.
• Marijuana smoking within 4 weeks prior to the Screening Visit, or expected smoking/inhalation during the study.

Where it is running

• Acorda Site #1003 — Long Beach, California, United States
• Acorda Site #1005 — Hallandale, Florida, United States
• Acorda Site #1002 — Orlando, Florida, United States
• Acorda Site #1004 — Atlanta, Georgia, United States
• Acorda Site #1001 — Farmington Hills, Michigan, United States

Full record on ClinicalTrials.gov

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