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. Author manuscript; available in PMC: 2018 Jul 1.
Published in final edited form as: Cancer Chemother Pharmacol. 2017 May 18;80(1):29–36. doi: 10.1007/s00280-017-3315-8

Table 3b. Summary of unbound plasma vismodegib Css in patients with normal or impaired hepatic function after oral administration of vismodegib (150 mg QD).

Unbound vismodegib, Css (μM) AAG concentration (μM)
Hepatic function Mean (±SD) Median (range) GMR (90% CI) Mean (±SD)
Normal* (n = 9) 0.233 (±0.098) 0.223 (0.100–0.441) Comparator 23.2 (±14.8)
Mild* (n = 8) 0.221 (±0.063) 0.218 (0.157–0.356) 0.99 (0.7–1.3) 25.4 (±12.5)
Moderate* (n = 6) 0.246 (±0.084) 0.217 (0.145–0.376) 1.09 (0.8–1.6) 27.1 (±14.0)
Severe* (n = 3) 0.227 (±0.085) 0.232 (0.140–0.310) 1 (0.6–1.7) 19.5 (±11.6)

AAG alpha-1 acid glycoprotein, Css average steady state concentration, QD once daily/

*

Normal (bilirubin [bili] < upper limit of normal [ULN]) ], mild (ULN < bili ≤ 1.5 × ULN), moderate (1.5 × ULN < bili ≤ 3 > ULN), and severe (3 × ULN < bili < 10 × ULN) liver dysfunction