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 range18 Years – 70 Years
SexALL
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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 trialï¼›
* 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 Screeningï¼›
* 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 5-6ï¼›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…
What they're measuring
1
Cmax
Timeframe: Day 1 to Day 7
2
Area Under Curve From 0 to Infinity (AUC0-infinity)