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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

NCT ID: NCT02812394

Last Updated: 2016-10-26

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parkinson Disease

Keywords

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Parkinson's disease Episodic motor fluctuations (OFF periods)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

CVT-301 (Dose Level 1)

Intervention Type 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)

Intervention Type DRUG

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

Sinemet®

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Sinemet®

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

Intervention Type DRUG

Other Intervention Names

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carbidopa/levodopa

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Acorda Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles Oh, MD

Role: STUDY_DIRECTOR

Acorda Therapeutics

Locations

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Site #001

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CVT-301-010

Identifier Type: -

Identifier Source: org_study_id