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Clinical Trial 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


Clinical Trial Description

A phase I, a single-center, non-randomized, open, single-dose administration study to explore the safety, pharmacokinetics of Larotinib in subjects with mild and moderate hepatic function impairment and healthy subjects with normal hepatic function. This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B for mild hepatic function impairment participants, cohort D for moderate hepatic function impairment, participants in cohort A and cohort B, group C and group D should be matched in terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both male and female, are planned to be enrolled. If a complete PK blood sample is not collected due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05048368
Study type Interventional
Source Sunshine Lake Pharma Co., Ltd.
Contact Jia Miao, MD
Phone +86 18980601806
Email miaosiyi1971@163.com
Status Not yet recruiting
Phase Phase 1
Start date December 30, 2023
Completion date December 30, 2024

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