Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or t… (NCT02119247) | Clinical Trial Compass
CompletedPhase 1
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
Belgium44 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Subject's written informed consent obtained prior to any study-related procedure
✓. Able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly
✓. Able to generate sufficient PIF
✓. Male and female subjects aged 18 to 55 years inclusive
✓. Body mass index (BMI) within the range of 18 to 30 kg/m2 inclusive
✓. Non- or ex-smokers who smoked \< 5 pack years
✓. Good physical and mental status
✓. Lung function within normal limits
Exclusion criteria
✕. Blood donation (equal or more than 450 ml) or blood loss less than 8 weeks before inhalation of the study medication
✕. Pregnant or lactating women
What they're measuring
1
Area under the plasma concentration-time curve of CHF 6001
Timeframe: 30 min and 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours after study drug administration at Period 1 and Period 2