COPD
Conditions
Interventions
After assessing eligibility during a screening period of up to 4 weeks, 18
subjects will be enrolled in this study. The study will consist of 3 periods,
each separated by a wash-out period of at lea
Sponsors
Phargentis SA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be healthy male or female subjects 18-50 years of age, inclusive. 2. Subjects must have normal lung function at Screening and prior to first dosing according to the investigator, e.g. FEV1 * 80% of the predicted normal value (inclusive). 3. Subject must be able to adequately follow the inhalation instructions and inhale correctly through both devices.
Exclusion criteria
Exclusion criteria: 1. A history of a clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) or any other clinically significant abnormality or disease. 2. An upper and/or lower respiratory tract infection within 3 weeks of Screening. 3. Any chronic and/or symptomatic upper or lower airway disease such as asthma, COPD, bronchiectasis, sarcoidosis, lung cancer, allergic airway disease (e.g. pollen allergy inside the relevant season or symptomatic to pets while daily exposed to them). 4. Current smokers (smoked in the previous 12 months or stopped smoking less than 12 months prior to Screening) or ex-smokers with more than 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 2 packs/day for 5 year).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * The area under the plasma concentration-time curve from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t). * The area under the plasma concentration-time curve from zero to infinity (AUC0-*). * The maximum plasma concentration (Cmax). * The time to reach maximum plasma concentration (tmax). * The terminal elimination rate constant (*z) with the respective half-life (t*). | — |
Secondary
| Measure | Time frame |
|---|---|
| * (Treatment emergent) adverse events * Physical examination * Vital signs * ECG * Spirometry * Clinical safety laboratory | — |
Countries
Netherlands
Outcome results
None listed