Table 2.
Parameter, arithmetic mean (SD) | Olanzapine | Samidorphan | ||
---|---|---|---|---|
Moderate hepatic impairment (N=10) | Healthy control (N=10) | Moderate hepatic impairment (N=10) | Healthy control (N=10) | |
Cmax (ng/mL) | 10.65 (4.21) | 4.91 (1.51) | 50.71 (13.6) | 30.77 (8.5) |
tmax (hr)a | 1.5 (0.5–4.0) | 7.0 (2.0–12.0) | 0.5 (0.5–1.0) | 1.0 (0.5–3.0) |
t1/2 (hr) | 53.3 (16.1) | 51.9 (18.0) | 11.9 (2.3) | 9.0 (0.8) |
AUClast (hr×ng/mL) | 376 (71) | 237 (129) | 397 (84) | 256 (64) |
AUC0-∞ (hr×ng/mL) | 424 (84) | 275 (149) | 408 (87) | 263 (65) |
CL/F (L/hr) | 12.2 (2.4) | 22.2 (9.0) | 25.5 (5.1) | 39.8 (8.2) |
Vz/F (L) | 920 (249) | 1555 (564) | 429 (86) | 514 (105) |
Note: aMedian (min, max) presented for tmax.
Abbreviations: AUClast, area under the plasma concentration-time curve from time 0 to last observed concentration above the lower limit of quantification; AUC0-∞, area under the plasma concentration-time curve from time 0 to infinity; CL/F, apparent clearance; Cmax, maximum observed concentration; OLZ/SAM, olanzapine/samidorphan; SD, standard deviation; tmax, time to maximum observed concentration; t½, terminal elimination half-life; Vz/F, apparent volume of distribution.