Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Acorda Therapeutics

Status and phase

Completed

Phase 1

Conditions

Parkinson's Disease

Treatments

Drug: Sinemet

Drug: CVT-301

Study type

Interventional

Funder types

Industry

Identifiers

NCT03887884

CVT-301-012

Details and patient eligibility

About

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.

Full description

The study duration includes a screening period followed by an overnight stay in the center (4 days, 3 nights) to complete 2 treatments, including a 48-hour interval between the treatments, and a follow-up phone call 1-2 days after discharge from the center.

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.

Enrollment

23 patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

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.