Table 2

Pharmacokinetic parameters collected in the VVZ-149 protocol

CmaxMaximum plasma concentration over the time span specified
Cmax,ssMaximum plasma concentration at steady state
Ctrough,ssPlasma concentration at a dosing interval after the treatment at steady state (trough concentration at steady state)
Cav,ssAverage plasma concentration during a dosing interval at steady state, calculated as AUCτ,ss/τt
ClastArea under the plasma concentration vs time curve, from time 0 to the last measurable concentration, calculated by the linear/log trapezoidal method
AUCinfThe area under the plasma concentration vs time curve from time 0 to infinity. AUCinf is calculated as the sum of AUClast plus the ratio of the last measurable plasma concentration to the elimination rate constant; AUCinf=AUClast+Clast/λZ
AUCτ,sstArea under the plasma concentration vs time curve during a dosing interval (τ) at steady state, calculated by the linear/log trapezoidal method
CL(VVZ-149 injection) The total body clearance after IV administration, calculated as dose/AUCinf
CL/F(VVZ-368) Apparent total body clearance after IV administration, calculated as dose/AUCinf
MRTMean residence time from the time of dosing to the time of the last measurable concentration. MRT=AUMClast/AUClast
PTFPeak-trough fluctuation, calculated as ((Cmax,ss—Ctrough,ss)/Cav,ss)×100 (%)
TmaxTime of the maximum measured plasma concentration
Tmax,ssTime of the maximum measured plasma concentration at steady state
t1/2Terminal half-life, calculated as ln(2)/λz
RAccumulation ratio, AUCτ,ss/AUC0−τt
Vd(VVZ-149 injection) The total volume of distribution after IV administration, calculated as dose/(AUCss×λ)
Metabolic ratioMetabolic ratio, AUClast of VVZ-368/AUClast of VVZ-149 injection
  • IV, intravenous.