Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function (NCT05048368) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function
China32 participantsStarted 2026-10-30
Plain-language summary
To evaluate the pharmacokinetics and safety of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects in a single-center, non-randomized, open, single-dose administration
Who can participate
Age range
18 Years – 70 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:
* healthy subjects with normal hepatic function (cohorts A and C) :
* 1\. Sign the informed consent form before the trial;
* 2\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m\^2, (including critical value) \[BMI= weight (kg)/height\^2 (m\^2)\] (BMI matching ±15% with liver dysfunction cohort);
* 3.Must be in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at Screening;
* 4.Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntarily take effective contraceptive measures.
* Subjects with mild/ Moderate hepatic Impairment (cohorts B and D) :
* 1\. Sign the informed consent form before the trial.
* 2\. subjects and must be 18 to 70 years of age inclusive, Male or female. body weight \>50 kg (male) or ≥45 kg (female) at screening. (BMI) : 18-30 kg/m\^2;
* 3\. Must satisfy the criteria for hepatic Impairment as evidenced by a Child-Pugh class of A or B at Screening:Class A; Mild; Child-Pugh score 5-6;Class B; Moderate; Child-Pugh score 7-9
* 4\. The liver function status of the subjects was determined to be stable between 1 month before taking the experimental drug and the end of the study, with no significant change.
* 5\. Subjects (including partners) have no pregnancy plan within 6 months after the last dose of study drug and voluntaril…
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
Timeframe: Day 1 to Day 7
2
Area Under Curve From 0 to Infinity (AUC0-infinity)