TABLE 3.

Model‐predicted geometric mean steady‐state C_max and AUC values for olanzapine and samidorphan after once‐daily doses of OLZ/SAM 10 mg/10 mg for 14 days in subjects with hepatic impairment compared with age‐matched healthy controls (model application)

Variable	Cmax,ss, ng/ml				AUCss, ng h/ml
	Healthy control	Mild HI	Moderate HI	Severe HI	Healthy control	Mild HI	Moderate HI	Severe HI
Olanzapine	34.4	40.9	51.2	53.2	688	783	1031	1077
Ratioa	—	1.19	1.49	1.55	—	1.14	1.50	1.57
Samidorphan	35.2	51.8	63.0	74.0	261	321	495	604
Ratioa	—	1.47	1.79	2.10	—	1.23	1.90	2.32

Abbreviations: AUC_ss, area under the plasma drug concentration‐time curve at steady state; C_max,_ss maximum plasma concentration at steady state; HI, hepatic impairment; OLZ/SAM, combination of olanzapine and samidorphan.

^a Relative to age‐matched controls with normal hepatic function.