NCT02812394

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-06-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2016-06-24
• Last updated: 2016-10-26

Locations

1 site across 1 country: United States