Table 5.
Overview of PK parameters after the first intravenous infusion of 1 mg to 200 mg BI 836826, for the combined population of Caucasian and Korean patients
| PK parameter | BI 836826 dose | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 mg | 3 mg | 9 mg | 25 mg | 50 mg | 100 mg | 150 mg | 200 mg | |
| n = 1 | n = 4 | n = 3 | n = 4 | n = 7 | n = 10 | n = 6 | n = 7 | |
| Cmax, norm (ng/mL/mg) | NC | 88.6 | 150 | 176 | 206 | 302 | 208 | 210 |
| AUC0-tz (ng•h/mL) | NC | 1670 (216) | 13,100 (135) | 75,000 (65.3) | 204,000 (166) | 770,000 (137) | 1,520,000 (28.5) | 1,870,000 (74.9) |
| t1/2 (hours) | NC | NC | NC | 8.95 (112) | 15.9 (62.2) | 27.6 (108) | 22.3 (41.8) | 33.8 (122) |
| AUC0-∞,norm (ng•h/mL/mg) | NC | NC | NC | 2990 | 6990 | 15,200 | 10,200 | 12,600 |
| CL (mL/min) | NC | NC | NC | 5.58 (90.6) | 2.38 (74.6) | 1.10 (101) | 1.63 (28.4) | 1.32 (84.9) |
| Vss (L) | NC | NC | NC | 5.07 (13.1) | 3.68 (33.9) | 2.82 (26.6) | 3.92 (20.8) | 4.50 (22.8) |
Data are shown as geometric mean (coefficient of variation, %)
AUC0-tz area under the curve over the time interval of one treatment course, AUC0-∞ area under the curve over the time interval from zero extrapolated to infinity, CL clearance, Cmax maximum concentration, norm normalized, NC not calculated, PK pharmacokinetic, t1/2 apparent terminal half-life of the analyte, Vss volume of distribution at steady state