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

Acorda Therapeutics

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: CVT-301 (Dose Level 2); Drug: CVT-301 (Dose Level 1); Drug: Sinemet®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02812394

CVT-301-010

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

CVT-301

Experimental group

Description:

CVT-301 (Dose Level 1): two (low dose) levodopa fine particle dose (FPD) capsules administered to the lung via oral inhalation using the CVT 301 inhaler. CVT-301 (Dose Level 2): two (high dose) levodopa FPD capsules administered to the lung via oral inhalation using the CVT 301 inhaler. Sinemet® (carbidopa/levodopa)

Treatment:

Drug: Sinemet®

Drug: CVT-301 (Dose Level 1)

Drug: CVT-301 (Dose Level 2)