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

October 24, 2016 updated by: Acorda Therapeutics

A Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) Tablets

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247
        • Site #001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CVT-301

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)
Drug: CVT-301 (Dose Level 1)
All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.
Drug: CVT-301 (Dose Level 2)
All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.
Drug: Sinemet®
All subjects will receive carbidopa/levodopa tablets administered every 8 hours.
Other Names:
  • carbidopa/levodopa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed plasma drug concentration (Cmax)
Time Frame: within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.
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.
within 15min pre-dose (baseline) and specified time points up to and @ 24h post-dose.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with Adverse Events (AEs) including Serious AEs
Time Frame: up to 9 days
up to 9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acorda Therapeutics

Investigators

  • Study Director: Charles Oh, MD, Acorda Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 22, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVT-301-010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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