NCT05216354

Fruquintinib Renal Impairment Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

A multicenter, open label, single-dose, single-period, sequential study to assess the effect of renal impairment on the pharmacokinetics of Fruquintinib

Detailed 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 severe and moderate renal impairment on the PK of Fruquintinib. The secondary objective is to evaluate the safety in subjects severe and moderate renal impairment and subjects with normal function. Initially, subjects with severe renal impairment and subjects with moderate renal impairment will be enrolled. Subjects with normal renal 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 renal impairment will be enrolled based on the renal function classification determined by Cockcroft-Gault scoring. Subjects with severe renal impairment will receive a single dose of 2 mg fruquintinib to account for potential increase in fruquintinib pharmacokinetic (PK) exposure. Subjects with moderate renal impairment or normal renal function will receive a single dose of 5 mg fruquintinib.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Fruquintinib	Fruquintinib will be administered as a single dose on the morning of Day 1 under fasting conditions

Timeline

• Start date: 2022-03-11
• Primary completion: 2023-06-26
• Completion: 2023-06-26
• First posted: 2022-01-31
• Last updated: 2023-08-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study