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

NCT06736223 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-01-12

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

ITF2357

ITF2357 (INNM Givinostat hydrochloride Monohydrate), single dose

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • Italfarmaco

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2025-08-13
Completion
2025-08-13
FDA Drug
Yes

Countries

  • Bulgaria
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06736223 on ClinicalTrials.gov