TABLE 4.

Dose proportionality of ST-246 assessed using pharmacokinetic parameter results (PK population)

Study day and parametera	Estimate of slope (β)b	SE of estimate of slope (β)	90% CI of estimate of slope (β)c
1
Cmax (ng/ml)	0.76	0.13	0.54-0.97
AUCtau (ng·h/ml)	0.74	0.14	0.50-0.98
6
Cmax (ng/ml)	0.59	0.11	0.41-0.78
AUCtau (ng·h/ml)	0.61	0.13	0.39-0.84
21
Cmax (ng/ml)	0.71	0.14	0.47-0.94
AUCtau (ng·h/ml)	0.70	0.15	0.45-0.96

^aActual values used (not dose normalized).

^bGeneral linear model was fitted to the data using the log-transformed model: log (parameter) = intercept + ß·log (dose) + error.

^cFor a tentative conclusion of dose proportionality of the dose-dependent parameters, the 90% CI for the slope should include 1.