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Table 1 Pharmacokinetics studies design and volunteers characteristics.

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

Study design

Treatment doses

Number of subjects

Age range (y)

M/F

Duration of treatment (and follow-up)

Single rising oral doses, double-blind, placebo-controlled, randomized

50, 100, 200, 400, 600 mg

40

21–39

M

Single dose (1-wk follow-up)

Repeat rising oral doses, double blind, placebo-controlled, randomized

50 mg every day, 100 mg every day, 200 mg every day, 100 mg twice a day

41

21–40

M

7 d (4 wks follow-up)

Single dose, food interaction study; open-label randomized

100 mg every day

24

25–39

M

Single-dose crossover