Table 3.

Statistical assessment of roxadustat exposure parameters after single-dose roxadustat administered to subjects with moderate hepatic impairment, compared with administration to subjects with normal hepatic function

Parameter	Moderate hepatic impairmenta [N = 8]	Normal hepatic functiona [N = 8]	GLSM ratio (%)b	90 % CI
AUC∞, ng·h/ml	60,108	48,967	122.75	86.1–175.1
C max, ng/ml	6928	8291	83.57	67.5–103.5
AUC∞,u, ng·h/ml	668	392	170	119.4–243.2
C max,u, ng/ml	77.0	66.4	116	93.1–144.6

AUC _∞ area under the concentration–time curve from the time of drug administration to infinity, CI confidence interval, C _max maximum concentration, GLSM geometric least-squares means, u unbound

^aData are expressed as GLSM

^bRatio defined as (GLSM moderate hepatic impairment)/(GLSM normal hepatic function)