TABLE 3

Comparison of predicted and observed PK parameters of risdiplam

DoseCmax
ng/ml
tmax
h
AUCinf
ng • h/ml
0.6 mg
Observation2.823.086.7
Prediction2.862.45112
2 mg
Observation8.333.0294
Prediction9.532.45373
6 mg fasted
Observation24.52.01080
Prediction28.62.451120
18 mg
Observation93.22.03290
Prediction85.82.453360
  • Data are presented as geometric means except for tmax (median).

  • AUCinf, AUC extrapolated to infinity; tmax, time to reach the maximum concentration AUC0-inf, area under the plasma concentration−time curve extrapolated to infinity; tmax, time to reach the maximum concentration.