NCT02633007

A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

A Phase 1 Study of the Safety and Pharmacokinetics (PK) of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

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

Summary

This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CVT-301 (levodopa inhalation powder)	Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
DRUG	Carbidopa	Administered orally according to the carbidopa dosing schedule.
OTHER	Placebo	Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.

Timeline

• Start date: 2015-12-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-12-17
• Last updated: 2016-06-13

Locations

3 sites across 1 country: United States