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

Phase 1 Completed 24 enrolled Italfarmaco Biotrial Inc. · collab

Non-randomizedSingle-groupOpen-labelBasic science

Summary

This was 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.

Timeline

Start: 2025-05-29
Primary completion: 2025-08-14
Completion: 2025-08-14

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Givinostat	Small molecule	50 mg	Oral

Indications

No indication recorded.