At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled / 24 target
Drug / intervention
ITF2357drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating ITF2357 for Hepatic Impairment. Completed, enrolled 24 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Impairment
CountriesBulgaria, France
CollaboratorsBiotrial
Timeline
Phase 1CompletedFinished
20252026
First PostedDec 2024
Enrollment StartMay 2025
Primary CompletionAug 2025
TodayJul 2026
First PostedDec 16, 2024
Enrollment StartMay 29, 2025
Primary CompletionAug 14, 2025
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 1.5 years ago
Arms & Interventions
Mild HIexperimental
Patients with mild HI (Child-Pugh class A)
Drug: ITF2357
Moderate HIexperimental
Patients with moderate HI (Child-Pugh class B)
Drug: ITF2357
Healthy Volunteersexperimental
Participants with normal hepatic function (control group)
Drug: ITF2357
Interventions
ITF2357drug
ITF2357 (INNM Givinostat hydrochloride monohydrate), single dose