Fruquintinib Hepatic Impairment Study

Hepatic Impairment Clinical Trial

Official title: An Open-Label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib

Status Completed

Clinical Trial Summary

An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Fruquintinib

Clinical Trial Description

This is a multicenter open-label, single-dose, single-period, sequential study in subjects without cancer with the primary objective of determining the effect of moderate and mild hepatic impairment on the PK of fruquintinib. The secondary objective is to evaluate the safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with normal hepatic function.

Initially, subjects with moderate hepatic impairment will be enrolled. An interim pharmacokinetic (PK) analysis will be performed to evaluate the need to enroll subjects with mild hepatic impairment. Subjects with normal hepatic function will be enrolled after all other subjects have completed the study and will be matched for sex, age and body mass index. Subjects with hepatic impairment will be enrolled based on the hepatic function classification determined by Child-Pugh scoring.

Subjects with moderate hepatic impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib PK exposure. Subjects with mild hepatic impairment or normal hepatic function will receive a single dose of 5 mg fruquintinib. ;

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

• NCT number: NCT05216367
• Study type: Interventional
• Source: Hutchmed
• Status: Completed
• Phase: Phase 1
• Start date: March 11, 2022
• Completion date: October 25, 2022