Table 1.
Summary of zanubrutinib PK parameters in healthy TQT study participants
| Parameter | Zanubrutinib dose | ||
|---|---|---|---|
| Part A | Part B | ||
| 480 mg (n = 6) | 160 mg (n = 28) | 480 mg (n = 30) | |
| Tmax, median (min, max), hour | 2.8 (1.0, 3.5) | 1.5 (1.0, 6.0) | 2.0 (0.5, 6.0) |
| Cmax, mean (CV%), ng/mL | 353 (33.5) | 216 (24.2) | 406 (30.7) |
| AUC0–t, mean (CV%), hour × ng/mL | 2,570 (36.2) | 1,160 (25.1) | 2,770 (28.9) |
| AUC0–∞, mean (CV%), hour × ng/mL | 2,670 (39.1) | 1,230 (23.5) | 3,060 (25.9) |
| t ½, mean (CV%), hour | 11 (50) | 5.3 (47) | 8.1 (68) |
| CL/F, mean (CV%), L/hour | 180 (39.2) | 126 (29.0) | 140 (38.8) |
| Vz/F, mean (CV%), L | 2,840 (41.0) | 966 (36.7) | 1,630 (55.8) |
AUC0– t, area under the concentration‐time curve from time zero to the last quantifiable concentration; AUC0–∞, area under the concentration‐time curve from time zero extrapolated to infinity; CL/F, apparent systemic clearance; Cmax, maximum observed concentration; CV, coefficient of variation; PK, pharmacokinetic; t ½, apparent terminal elimination half‐life; Tmax, time to maximum observed concentration; TQT, thorough QT; Vz/F, apparent volume of distribution during the terminal elimination phase.