NCT02905227

A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder

A Phase 1 Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder in Chronic Smokers and People With Mild or Moderate Asthma Compared to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Acorda Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is an open-label, parallel group study to evaluate acute pulmonary safety and Pharmacokinetics (PK) of two doses, separated by 2 hours, of CVT-427 zolmitriptan inhalation powder in three groups of adults: those with asthma, those who smoke and healthy volunteers.

Detailed description

The purpose of this study is to evaluate acute pulmonary safety and PK of CVT-427 zolmitriptan inhalation powder in the study populations.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	CVT-427 (zolmitriptan inhalation powder)	Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.

Timeline

• Start date: 2016-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2016-09-19
• Last updated: 2018-02-14

Locations

3 sites across 1 country: United States