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

NCT02119247 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2014-08-01

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CHF 6001 dry powder for inhalation via NEXThaler®

DEVICE

CHF 6001 DPI capsules for inhalation via Aerolizer

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Joe Leempoels, MD · SGS CPU Antwerpen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02119247 on ClinicalTrials.gov