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A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

NCT02633839 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-07-14

No results posted yet for this study

Summary

This is an open label, parallel group study to evaluate the pharmacokinetics (PK) and safety of a single dose of CVT-301 in smoking and non-smoking adults.

Conditions

  • Smoking

Interventions

DRUG

CVT-301

Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.

DRUG

Carbidopa

Administered orally according to the carbidopa dosing schedule.

Sponsors & Collaborators

  • Acorda Therapeutics

    lead INDUSTRY

Principal Investigators

  • Harald Murck, MD, PhD · Acorda Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633839 on ClinicalTrials.gov