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

Acorda Therapeutics24 enrolled

Overview

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.

The primary objective is to determine the relative bioavailability of two CVT-301 (dose levels 1 and 2) capsules compared with the Reference Listed Drug (RLD) on a per milligram basis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson Disease

Interventions

CVT-301 (Dose Level 1)DRUG

All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.

CVT-301 (Dose Level 2)DRUG

All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.

Sinemet®DRUG

All subjects will receive carbidopa/levodopa tablets administered every 8 hours.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (1)

Site #001

Dallas, Texas, United States

Outcomes

Primary Outcomes

Maximum observed plasma drug concentration (Cmax)

Time frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.

Area under the plasma concentration curve from time 0 to the concentration at 24 hours (AUC0-24h)

Time frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.

Secondary Outcomes

Number of subjects with Adverse Events (AEs) including Serious AEs

Time frame: up to 9 days

Data from ClinicalTrials.gov

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