NCT02633839

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

A Phase 1 Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-04-01
• Completion: 2016-06-01
• First posted: 2015-12-17
• Last updated: 2016-07-14

Locations

2 sites across 1 country: United States