NCT05048368

Pharmacokinetics Study of Larotinib in Subjects With Impaired Hepatic Function

A Pharmacokinetic Study of Larotinib in Subjects With Mild/Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Sunshine Lake Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Esophageal Cancer
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	Larotinib	Capsules, Oral, 350 mg, single dose, one day

Timeline

• Start date: 2026-10-30
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2021-09-17
• Last updated: 2025-05-18

Locations

1 site across 1 country: China