Skip to main content

Table 2 Pharmacokinetics parameters after single rising dose to healthy volunteers.

From: Pharmacokinetics, Safety and Inducible Cytokine Responses during a Phase 1 Trial of the Oral Histone Deacetylase Inhibitor ITF2357 (Givinostat)

Dose

 

50 mg

100 mg

200 mg

400 mg

600 mg

C max

ng/mL

53 ± 5

99 ± 13

236 ± 25

526.3 ± 67.3

542 ± 93

nmol/L

111 ± 10

207 ± 28

495 ± 53

1,106 ± 141

1,139 ± 195

tmax

(h)

2.0 ± 0.44

2.09 ± 0.45

2.17 ± 0.40

2.17 ± 0.40

3.67 ± 0.61

AUC

ng · h/mL

359 ± 26

671 ± 36

1,346 ± 158

2,503 ± 312

3,543 ± 486

nmol/L · h

754 ± 55

1,410 ± 76

2,828 ± 332

5,259 ± 656

7,444 ± 1,021

Half-life

(h)

6.9 ± 0.43

6.0 ± 0.15

6.0 ± 0.40

5.7 ± 0.32

5.3 ± 0.32

CL/Fa

(L/min)

2.38 ± 0.17

2.52 ± 0.14

2.64 ± 0.28

2.96 ± 0.49

3.15 ± 0.51

  1. aClearance fluid compartment.