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 2025-05-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 \[or if out of range, considered not clinically significant (NCS) by the Investigator\]:
✓. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation oral, intravaginal or transdermal.
✓. progestogen-only hormonal contraception associated with inhibition of ovulation oral, injectable or implantable
✓. intrauterine device (IUD)
✓. intrauterine hormone-releasing system (IUS)
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Maximum plasma concentration observed (Cmax) of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
2
Area under the plasma concentration versus time curve to the real time tlast (AUClast) of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
3
Area under the plasma concentration versus time curve extrapolated to infinity (AUC0-inf) of ITF2357
Timeframe: Pre-dose (30 minutes before administration), then 0.5 to 96-hour post-dose
✕. 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 changing 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.