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To compare results of population PK analyses obtained with a full empirical design (FD) and an optimal sparse design (MD) in a Drug-Drug Interaction (DDI) study aiming to evaluate the potential CYP3A4 inhibitory effect of a drug in development, SX, on a reference substrate, midazolam (MDZ). Secondary aim was to evaluate the interaction of SX on MDZ in the in vivo study. Methods To compare designs, real data were analysed by population PK modelling technique using either FD or MD with NONMEM FOCEI for SX and with NONMEM FOCEI and MONOLIX SAEM for MDZ. When applicable a Wald test was performed to compare model parameter estimates, such as apparent clearance (CL/F), across designs. To conclude on the potential interaction of SX on MDZ PK, a Student paired test was applied to compare the individual PK parameters (i.e. log(AUC) and log(C(max))) obtained either by a non-compartmental approach (NCA) using FD or from empirical Bayes estimates (EBE) obtained after fitting the model separately on each treatment group using either FD or MD.

journal of pharmacokinetics and pharmacodynamics

Drug–drug interaction predictions with PBPK models and optimal multiresponse sampling time designs: application to midazolam and a phase I compound. Part 2: clinical trial results