Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairm… (NCT06736223) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics, Safety and Tolerability of ITF2357 in Participants With Chronic Hepatic Impairment and With Normal Hepatic Function
Bulgaria, France24 participantsStarted 2025-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female participants, between 18 and 75 years of age, inclusive.
. Body weight between 60.0 and 110.0 kg, inclusive if male, and between 50.0 and 100.0 kg, inclusive if female, body mass index (BMI) between 18.00 and 34.99 kg/m2, inclusive.
. Stable chronic liver disease assessed by medical history, physical examination, laboratory values.
. Vital signs after 10 minutes resting in supine position within the following range \[or if out of range, considered not clinically significant (NCS) by the Investigator\]: 95 mmHg \< systolic blood pressure (SBP) \< 180 mmHg; 45 mmHg \< diastolic blood pressure (DBP) \< 100 mmHg; 40 bpm \< heart rate (HR) \< 100 bpm.
. 12-lead ECG without clinically significant abnormality, in the judgment of the Investigator; in no circumstances were participants enrolled with corrected QT according to Fridericia (QTcF) \> 450 ms.
. Any confirmed clinically relevant abnormal laboratory test that, on Investigator's judgment, was inconsistent with the subject's status as a patient with hepatic impairment. However, renal function assessed using the estimated glomerular filtration rate (eGFR) calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula had to be strictly above 60 mL/min/1.73m².
. Female participants who were not pregnant or nursing at screening and D-1, or who were not planning to become pregnant during study period and until 90 days after the IMP administration.
. Female participants of non-childbearing potential, defined as one of the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cmax of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
2
AUClast of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
3
AUC0-inf of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
. Uncontrolled clinically relevant cardiovascular, pulmonary, gastrointestinal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynecological (if female), or infectious disease, or signs of acute illness.
. Hepatocarcinoma.
. Acute hepatitis.
. Hepatic encephalopathy grade 2, 3, and 4.
. Blood donation within 2 months before inclusion.
. Symptomatic postural hypotension, whatever the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in SBP ≥ 30 mmHg within 3 minutes when changed from supine to standing position.
. Presence or history of drug hypersensitivity, or allergic disease, except seasonal rhinitis, diagnosed and treated by a physician.
. History or presence of regular use of recreational drugs or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis) within 2 years before inclusion.