TABLE 7

Clinically observed and Simcyp model-predicted PK parameters of panobinostat administered as a single oral 20-mg single dose with (1 hour after fourth KTZ dose) and without KTZ 400 mg orally dosed once a day for 5 days

PK ParameteraPanobinostat AlonePanobinostat + KTZGeometric Mean Ratio (90% CI)
Cmax ng/mlObservedb (n = 14)18.52 (42.6)29.98 (93.3)1.6 (1.2–2.2)
Predicted (n = 100)9.67 (146)16.5 (154)1.7 (1.6–1.8)
Prediction error (%)c−48−456
AUC0-∞ ng × h/mlObserved (n = 11–12)133.0 (39.9)220.7 (54.6)1.8 (1.5–2.2)
Predicted (n = 100)225 (48)401 (48)1.8 (1.7–1.9)
Prediction error (%)+69+820
  • a Values are the geometric mean (CV%).

  • b Observed values are from Hamberg et al. (2011).

  • c Prediction error % = [(predicted-observed)/observed] × 100.