Table 2.

Summary of Statistical Analysis of Primary PK Parameters of Capmatinib Before and After Coadministration of Itraconazole or Rifampicin (PK Analysis Set)

			Treatment Comparison (Perpetrator Drug + Capmatinib/Capmatinib Alone)
PK Parameter	N a	Adjusted Geometric Mean	Geometric Mean Ratio (90%CI)
Capmatinib (perpetrator drug, itraconazole)
AUCinf (ng · h/mL)
Capmatinib alone	25	5180	1.42 (1.33–1.52)
Perpetrator + capmatinib	22	7360
AUClast (ng · h/mL)
Capmatinib alone	26	5220	1.41 (1.29–1.53)
Perpetrator + capmatinib	22	7340
Cmax (ng/mL)
Capmatinib alone	26	1260	1.03 (0.866–1.22)
Perpetrator + capmatinib	22	1300
Tmax (h)
Capmatinib alone	26	1.00	0.489 (–3.02 to 3.00)
Perpetrator + capmatinib	22	2.00
Capmatinib (perpetrator drug, rifampicin)
AUCinf (ng · h/mL)
Capmatinib alone	24	11,500	0.335 (0.300–0.374)
Perpetrator + capmatinib	18	3850
AUClast (ng · h/mL)
Capmatinib alone	25	11,600	0.322 (0.294–0.353)
Perpetrator + capmatinib	23	3720
Cmax (ng/mL)
Capmatinib alone	25	3070	0.441 (0.387–0.502)
Perpetrator + capmatinib	23	1350
tmax (h)
Capmatinib alone	25	0.994	–0.0317 (–1.05 to 1.01)
Perpetrator + capmatinib	23	0.994

AUC_inf, area under the plasma concentration–time curve from time 0 to infinity; AUC_last, area under the plasma concentration–time curve from time 0 to the last quantifiable concentration point; C_max, maximum plasma drug concentration; PK, pharmacokinetic; t_max, time to reach maximum plasma drug concentration.

For T_max, median is presented under Adjusted Geometric Mean, median difference under Geometric Mean Ratio, and minimum and maximum differences under 90%CI.

^aN = number of observations used for analysis.