Non-Cystic Fibrosis Bronchiectasis with Pseudomonas Aeruginosa or other Potentially Pathogenic Micro-organisms
Conditions
Brief summary
1. Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs)., 2. Changes in clinical laboratory values (haematology, clinical chemistry) at each time point., 3. Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and oxygen saturation (SpO2) at each time point.
Detailed description
Plasma PK parameters peak serum concentration (Cmax), time to peak serum concentration (Tmax), area under the concentration-time curve from dosing (time 0) to time t (AUC0-t), area under the concentration-time curve from dosing (time 0) to end of dosing period (AUC0-tau), area under the concentration-time curve for total drug exposure from dosing (time 0) extrapolated to infinity (AUC0-inf), trough plasma concentration (Ctrough), and half-life (t1/2).
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence, intensity, causality, and seriousness of treatment-emergent adverse events (TEAEs)., 2. Changes in clinical laboratory values (haematology, clinical chemistry) at each time point., 3. Changes in vital signs (blood pressure, heart rate, temperature, respiratory rate) and oxygen saturation (SpO2) at each time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma PK parameters peak serum concentration (Cmax), time to peak serum concentration (Tmax), area under the concentration-time curve from dosing (time 0) to time t (AUC0-t), area under the concentration-time curve from dosing (time 0) to end of dosing period (AUC0-tau), area under the concentration-time curve for total drug exposure from dosing (time 0) extrapolated to infinity (AUC0-inf), trough plasma concentration (Ctrough), and half-life (t1/2). | — |
Countries
Bulgaria, Poland, Romania