Drug Drug Interaction Clinical Trial
Official title:
An Open-label, Single-center, Study in Healthy Subjects to Evaluate the Plasma and Urine Pharmacokinetics of Givinostat and Its Metabolites Following Single and Multiple Oral Doses of Givinostat (Part 3).
Primary objective: To evaluate the plasma and urine PK of givinostat following multiple oral doses of givinostat. Secondary objective: To assess the safety and tolerability multiple oral doses of givinostat.
This study was planned as a phase I, open-label, 3-part, fixed-sequence, nonrandomized study in healthy male and female subjects. The study (Part 3) aimed at assessing Givinostat and its metabolites (ITF2374, ITF2375, ITF2440 and ITF2563) plasma and urine concentrations and thereof derived pharmacokinetic parameters following single oral dose administration of givinostat (day 1) and following multiple oral dose administration of givinostat (day 5 to day 13). More precisely, Gmean and corresponding 95% CI of givinostat plasma and urine concentration and givinostat metabolites plasma concentration versus time profiles following single (Day 1) and multiple-dose (Day 5 to Day 13) administration of givinostat are reported using Linear Scale and Semi- Logarithmic Scale. Descriptive statistics of givinostat plasma pharmacokinetic parameters and givinostat metabolites PK parameters following single-dose administration of givinostat (day 1) and following multiple-dose administration of givinostat (Day 13) were calculated. Descriptive statistics of givinostat and its metabolites urinary excretion profile following single-dose administration of givinostat (day 1) and following multipledose administration of givinostat (Day 13) were calculated. Descriptive statistics of givinostat and its metabolites cumulative amount of urinary excretion profile following single-dose administration of givinostat (day 1) and following multiple-dose administration of givinostat (Day 13) were also calculated using linear scales. ;
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