TABLE 4.

Simulated and observed human PK parameters of delamanid after 100 mg oral dose and the prediction accuracy^c

Parameter	Predicted PK parameter of:		Observed value	Fold error differencea of:
	Css-MRTb	PBPK modeling		Css-MRTb	PBPK modeling
Cmax (ng/ml)	46.6	203.4	198.4	0.23	1.02
tmax (h)	5	2	4	1.25	0.50
AUC168h (ng·h/ml)	2,826	4,381	3,150	0.90	1.39
AUC∞ (ng·h/ml)	3,004	4,385	3,168	0.95	1.38
t1/2 (h)	41.0	16.7	23.7	1.73	0.71

^aPredicted value versus observed value ratio was calculated.

^bIn the C_ss-MRT approach, the human PK profile after a single oral administration of delamanid was simulated using the one-compartment model with first-order absorption kinetics.

^cThe k_a, lag time, k_el, V, and F used values of 0.85 h⁻¹, 0.69 h, 0.0177 h⁻¹, 7.73 liter/kg, and 0.36, respectively.