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

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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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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