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. Author manuscript; available in PMC: 2017 Jul 3.
Published in final edited form as: Leuk Lymphoma. 2015 Feb;56(2):395–400. doi: 10.3109/10428194.2014.918970

Table 3.

SAR103168 plasma pharmacokinetics parameters (course 1).

Plasma SAR103168, mean ± SD (geometric mean) [CV%]
1.2 mg/m2 1.7 mg/m2 2.4 mg/m2 4.8 mg/m2 9.6 mg/m2 14.4 mg/m2
Day 1 n = 5 n = 4 n = 5 n = 3 n = 5 n = 4
Cmax (ng/mL) 69.4 ± 29.4 (61.9) [42.4] 78.3 ± 15.6 (77.0) [19.9] 140 ± 70.4 (125) [50.2] 204 ± 83.2 (194) [40.7] 259 ± 43.8 (256) [16.9] 533 ± 198 (501) [37.2]
tmax* (h) 0.92 (0.50–7.00) 0.50 (0.50–0.83) 0.92 (0.50–0.92) 0.92 (0.50–0.92) 1.00 (0.67–1.42) 0.88 (0.50–0.92)
AUClast (ng.h/mL) 109 ± 60.1 (96.0) [55.1] 75.5 ± 21.6 (73.4) [28.7] 283 ± 340 (164) [120.3] 217 ± 66.3 (211) [30.6] 744 ± 800 (543) [107.5] 822 ± 265 (784) [32.3]
Day 5 n = 7 n = 4 n = 5 n = 3 n = 5 n = 4
Cmax (ng/mL) 63.9 ± 47.8 (51.9) [74.8] 170 ± 144 (138) [84.8] 350 ± 546 (156) [155.8] 238 ± 81.5 (228) [34.3] 291 ± 76.9 (282) [26.5] 467 ± 255 (420) [54.6]
tmax* (h) 0.92 (0.50–3.95) 0.96 (0.92–1.33) 1.08 (0.92–1.28) 0.92 (0.50–0.92) 0.92 (0.88–1.00) 0.90 (0.50–1.00)
AUClast (ng.h/mL) 45.7 ± 40.2 (31.5) [87.9] 228 ± 171 (176) [74.8] 468 ± 761 (193) [162.7] 577 ± 179 (560) [31.0] 987 ± 1140 (681) [115.5] 992 ± 684 (3.49) [114.3]
T1/2z (h) NC ± NC (NC) [NC] NC ± NC (NC) [NC]§ 4.35 ± 5.13 (2.41) [117.8] NC ± NC (NC) [NC] 3.32 ± 2.69 (2.62) [80.9] 5.46 ± 6.24 (3.49) [114.3]

Cmax, peak plasma concentration; tmax, time of peak plasma concentration; AUClast, area under the curve up to last measurement; t1/2z, terminal exponential half-life; SD, standard deviation; CV, coefficient of variation; NC, not calculated.

*

Median (min-max).

n = 4.

n = 1.

§

n = 0.

n = 2.