Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)



Status:Recruiting
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 85
Updated:3/27/2019
Start Date:March 5, 2019
End Date:August 19, 2019
Contact:Charles Oh, MD
Email:coh@acorda.com
Phone:914-326-5455

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Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's Disease

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.

On each of two treatment days, subjects will consume a standard high fat meal and then
receive either (A) a single inhaled dose of CVT-301 or (B) a single dose of oral CD/LD
followed by Pharmacokinetic (PK) sampling for 4 hours. A crossover design will be used such
that each subject receives both Treatment A and Treatment B over the 2 treatment days,
randomized 1:1 to the treatment sequence AB or BA.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
6
sites
Farmington Hills, Michigan 48334
Principal Investigator: Aaron Ellenbogen, DO
Phone: 248-957-8940
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Atlanta, Georgia 30329
Principal Investigator: Robert Riesenberg, MD
Phone: 404-881-5800
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Atlanta, GA
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Berlin, New Jersey 08009
Principal Investigator: Howard Hassman, MD
Phone: 856-753-7335
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Berlin, NJ
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Hallandale Beach, Florida 33009
Principal Investigator: Beth Safirstein, MD
Phone: 954-455-5757
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Hallandale Beach, FL
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Long Beach, California 90806
Principal Investigator: Omid Omidvar, MD
Phone: 562-304-1742
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Long Beach, CA
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Orlando, Florida 32806
Principal Investigator: Ira Goodman, MD
Phone: 407-210-1307
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Orlando, FL
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