Table 7.

Pharmacokinetic parameters of vilaprisan (VPR) metabolite M-4 (BAY 1139463) in pooled plasma samples of 14 subjects after single oral administration of VPR 4 mg with and without concomitant administration of itraconazole (ITZ) 200 mg/day (drug–drug interaction study)

Parameter	Unit	VPR	VPR + ITZ
${\text{AUC}}_{0-t_{\text{last}}}$	µg·h/L	18.7	409
AUC0–24	µg·h/L	29.6	48.7
C max	µg/L	3.02	5.67
t 1/2	h	26.4	303
t last	h	12	264
t max	h	2.00	2.00

AUC_0–t area under the concentration–time curve from time zero to time t, C_max maximum plasma concentration, t_1/2 terminal half-life, t_last time of last concentration above lower limit of quantitation, t_max time to reach C_max

Note: Pooled samples were used for exploratory quantitation of M-4. The extrapolated fraction of the AUC exceeded 50% for both treatments so that AUCs are not provided here