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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 3a. Summary of vismodegib PK parameters in plasma in patients with normal or impaired hepatic function after oral administration of vismodegib (150 mg QD).

Parameter Normal* n = 9 Mild* n = 8 Moderate* n = 6 Severe* n = 3
AUC0–24 h (μM h) Median 409 605 562 368
GMR (90% CI) Comparator 1.24 (0.9–1.7) 1.31 (0.9–1.9) 0.86 (0.5– 1.4)
Cmax, μM  Median 18.1 27.4 26.9 17.1
GMR (90% CI) Comparator 1.3 (0.95–1.8) 1.3 (0.9–1.8) 0.87 (0.5– 1.4)
Css, μM Median 17 24.3 24.5 15.7
GMR (90% CI) Comparator 1.24 (0.9–1.7) 1.27 (0.9–1.8) 0.88 (0.6– 1.4)

AAG alpha-1-acid glycoprotein, AUC area under the curve, CI confidence interval, Cmax peak serum concentration, Css average steady state concentration, GMR geometric mean ratio.

*

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