Table 2.
Pharmacokinetic parameter estimates for AMG 986 200 mg and 400 mg after oral administration in healthy Japanese subjects
| Cmax, ng/mL | Cmax/dose, ng/mL/mg | AUClast, h ng/mL | AUClast/dose, h ng/mL/mg | AUC∞, h ng/mL | AUC∞/dose, h ng/mL/mg | tmax, h | t½, h | |
|---|---|---|---|---|---|---|---|---|
| AMG 986 200 mg | ||||||||
| Mean (SD) | 15,800 (3640) | 79.2 (18.2) | 89,100 (20,500) | 445 (102) | 88,700 (22,900) | 444 (115) | – | 15.1 (3.2) |
| Median (range) | – | – | – | – | – | – | 1.0 (1.0–2.0) | – |
| Geometric mean (CV%) | 15,500 (23.2) | 77.5 (23.2) | 86,600 (28.2) | 433 (28.2) | 85,800 (31.4) | 429 (31.4) | 1.3 (37.4) | 14.8 (20.3) |
| AMG 986 400 mg | ||||||||
| Mean (SD) | 21,000 (7300) | 52.4 (18.3) | 104,000 (43,100) | 259 (108) | 105,000 (44,900) |
263 (112) |
– | 17.6 (3.8) |
| Median (range) | – | – | – | – | – | – | 1.0 (0.5–1.0) | – |
| Geometric mean (CV%) | 19,400 (50.0) | 48.6 (50.0) | 95,700 (48.2) | 239 (48.2) | 96,700 (49.1) | 242 (49.1) | 0.80 (36.3) | 17.2 (23.0) |
AUC∞ area under the plasma concentration-time curve from time zero to infinity, AUC∞/dose dose-normalized AUC∞, AUClast area under the plasma concentration-time curve from time zero to the last quantifiable time point postdose, AUClast/dose dose-normalized AUClast, Cmax maximum observed plasma concentration, Cmax/dose dose-normalized Cmax, CV% coefficient of variation, SD standard deviation, t½ terminal half-life, tmax time to maximum concentration