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Completed

NCT Number: NCT02812394

A 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site #001

Dallas, Texas, 75247, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: carbidopa/levodopa

Primary outcomes

  1. Maximum observed plasma drug concentration (Cmax)

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

  2. 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

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

    Time frame: up to 9 days

Sponsors and collaborators

Lead sponsor

Acorda Therapeutics

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2016
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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