NCT06736223

Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function

A Multicentric, Open-label, Non-randomized Study to Evaluate the Pharmacokinetic, Safety and Tolerability of ITF2357 Given as an Oral Single 50 mg Dose in Participants With Chronic Hepatic Impairment Relative to Matched Participants With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 in participants with chronic hepatic impairment relative to matched participants with normal hepatic function.

Detailed description

This study will evaluate the effect of mild and moderate hepatic impairment (HI) on the pharmacokinetics of ITF2357 and its metabolites. The total number of participants to be enrolled in the study is 24 subjects: * 8 Participants with mild HI (Child-Pugh class A) * 8 Participants with moderate HI (Child-Pugh class B) * 8 Participants with normal hepatic function (control group) Each participant will go through: * A screening period from Day (D)-28 to D-2 * One 6-day/5-night inpatient period (from D-1 evening to D5 morning) * An end-of-study evaluation to be done on D10 (±1 day).

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	ITF2357	ITF2357 (INNM Givinostat hydrochloride Monohydrate), single dose

Timeline

• Start date: 2025-05-28
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2024-12-16
• Last updated: 2026-01-12

Locations

3 sites across 2 countries: Bulgaria, France

Regulatory

• FDA-regulated drug study