Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2019-06-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

It is a 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 patients who regularly take CD/LD.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CVT-301

Single inhaled dose of CVT-301 84 mg

Group Type EXPERIMENTAL

CVT-301

Intervention Type DRUG

Levodopa Inhalation Powder

Sinemet

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Group Type ACTIVE_COMPARATOR

Sinemet

Intervention Type DRUG

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Interventions

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CVT-301

Levodopa Inhalation Powder

Intervention Type DRUG

Sinemet

Single oral dose of Carbidopa/Levodopa 25 mg/100 mg

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No