Primary end-point(s) | Secondary end-point(s) | Further end-points | Further safety parameters of interest | |
Single-rising-dose | Drug-related adverse events | Cmax AUC0–1 | tmax AUC0–∞ CL/F t1/2 | Physical examination Safety laboratory tests 12-lead ECG Continuous ECG monitoring Vital signs Spirometry (FEV1, FVC and FEF25–75) Palatability |
Multiple-rising-dose | Drug-related TEAEs | Physical examination Safety laboratory tests Serum and urine electrolytes 12-lead ECG Vital signs Spirometry | ||
First dose | Cmax AUC0–12 | tmax t1/2 fe0–12 | ||
Last dose | Cmax,ss AUCτ,ss | tmax,ss RACmax RAAUC0–12 fe0–12,ss | ||
Bioavailability | AUC0–∞ | Cmax tmax | Physical examination Safety laboratory tests 12-lead ECG Vital signs |
Cmax: maximum measured concentration of BI 1265162 in plasma after single dose; AUC0–1: area under the curve of BI 1265162 in plasma from dosing to 1 h post-dosing; tmax: time administered drug excreted from last dosing to the maximum concentration of BI 1265162 in plasma after single dose; AUC0–∞: area under the concentration–time curve of BI 1265162 in plasma over the time interval from 0 extrapolated to infinity; CL/F: apparent clearance; t1/2: observed terminal elimination half-life of BI 1265162 in plasma; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; FEF25–75: forced expiratory flow between 25% and 75% of the FVC; TEAE: treatment-emergent adverse event; AUC0–12: area under the curve of BI 1265162 in plasma over a 12-h period after single dose; fe0–12: fraction of administered drug excreted unchanged in urine over a 12-h period after single dose; Cmax,ss: maximum measured concentration of BI 1265162 in plasma at steady state; AUCτ,ss: area under the curve of BI 1265162 in plasma over a 12-h period at steady state; tmax,ss: time administered drug excreted from last dosing to the maximum concentration of BI 1265162 in plasma at steady state; RACmax: accumulation ratio based on Cmax,ss; RAAUC: accumulation ratio based on AUC0–12 and AUCτ,ss; fe0–12,ss: fraction of administered drug excreted unchanged in urine over a 12-h period at steady state.