NCT05860114

Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)

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).

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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 12, with measures reported at Day 13, before single-dose administration). 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 12, with measures reported at 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 (Days 5-12, with measures reported at Day 13) were calculated. Descriptive statistics of Givinostat and its metabolites urinary excretion profile following single-dose administration of Givinostat (Day 1) and following multiple dose administration of Givinostat (Days 5-12, with measures reported at 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 (Days 5-12, with measures reported at Day 13) were also calculated using linear scales.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Givinostat	Drug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension On days 1 and 13 givinostat was administered in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. Moreover the subjects were in a semi-recumbent position and remained semi-recumbent until at least 4 hours post-dose.No fluids were allowed from 1 hour before dosing until 2 hours post-dose. Water was provided ad libitum at all other times. From Day 5 to Day 12, subjects received givinostat 50 mg as oral suspension, twice a day, in the morning and in the evening.

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-05-08
• Completion: 2022-05-24
• First posted: 2023-05-16
• Last updated: 2025-01-24
• Results posted: 2025-01-24

Locations

1 site across 1 country: Portugal

Regulatory

• FDA-regulated drug study