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Table 3 Summary of pharmacokinetic parameters of TP3076 and TP3011

From: Phase I study of TP300 in patients with advanced solid tumors with pharmacokinetic, pharmacogenetic and pharmacodynamic analyses

TP3076 Dose (mg/m2) 1 2 4 6 8 10 12
Parameter N 3 3 3 3 3 12 4
Cmax (ng/mL) Mean 26.1 76.9 152 185 196 326 688
S.D. 7.46 3.65 56.4 29.8 56.1 99.4 209
AUC (ng*h/mL) Mean 52.9 209 335 405 451 1000 2450
S.D. 8.26 103 130 120 87.8 476 1330
tmax (h) Mean 1.26 0.966 1.02 1.01 1.10 1.07 0.983
S.D. 0.242 0.0289 0.168 0.0587 0.137 0.111 0.0236
t1/2 (h) Mean 2.35 3.73 7.04 5.97 6.22 5.14 4.93
S.D. 0.990 1.33 3.30 0.951 0.979 1.08 0.535
fe (%) Mean 2.45 2.87 1.31 1.78 1.71 3.09 6.33
S.D. 1.14 0.769 0.830 1.46 1.02 2.52 1.20
TP3011 Dose (mg/m2) 1 2 4 6 8 10 12
Parameter N 3 3 3 3 3 12 4
Cmax (ng/mL) Mean 3.13 9.12 38.3 32.5 34.2 89.5 150
S.D. 1.97 4.93 23.5 16.4 12.0 82.3 80.5
AUC (ng*h/mL) Mean 35.1 94.0 284 379 427 1300 2030
S.D. 24.8 77.2 140 259 114 1640 1590
tmax (h) Mean 3.21 2.66 2.58 3.84 3.11 4.59 5.27
S.D. 1.74 0.601 0.811 1.98 1.83 1.62 2.06
t1/2 (h) Mean 6.92 6.56 7.18 10.0 9.52 8.60 7.41
S.D. 3.15 2.66 2.87 2.87 1.72 1.95 1.13
fe (%) Mean 0.792 0.739 0.796 0.593 0.594 1.10 1.99
  S.D. 0.676 0.279 0.633 0.492 0.385 0.987 1.59