NCT02119247

Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device

OPEN-LABEL, RANDOMIZED, 2-WAY CROSS-OVER, SINGLE DOSE STUDY IN HEALTHY VOLUNTEERS TO INVESTIGATE THE PHARMACOKINETICS OF CHF 6001 DPI ADMINISTERED USING THE MULTI-DOSE RESERVOIR NEXThaler® DEVICE OR THE CAPSULE FOR ORAL INHALATION VIA AEROLIZER® DEVICE

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®. CHF 6001 is an antinflammatory drug under development for Chronic obstructive pulmonary disease (COPD) therapy. The drug is presented as dry powder for inhalation delivered by an inhaler device. Previous studies were conducted using a single-dose capsule inhaler (Aerolizer®) device. For the subsequent clinical studies a novel multi-dose NEXThaler® device will be used.

Detailed description

This is an Open-label, randomized, 2-way cross-over, Phase I study. The study is conducted in 1 single european site. The main scope of the study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 DPI administered using the multi-dose reservoir NEXThaler® device or the single-dose capsule Aerolizer® device.

Conditions

• COPD

Interventions

Type	Name	Description
DEVICE	CHF 6001 dry powder for inhalation via NEXThaler®
DEVICE	CHF 6001 DPI capsules for inhalation via Aerolizer

Timeline

• Start date: 2014-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2014-04-21
• Last updated: 2014-08-01

Locations

1 site across 1 country: Belgium