NCT05954169

Pharmacokinetic/Pharmacokinetic and Safety Studies of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

A Single-dose, Open-label/Pharmacokinetic and Safety Study of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of SHR4640 tablets in subjects with moderate renal insufficiency and healthy subjects, and to explore the relationship between renal function (e.g., eGFR) and SHR4640 pharmacokinetic and pharmacodynamic parameters.

Conditions

• Hyperuricemia

Interventions

Type	Name	Description
DRUG	SHR4640	SHR4640 single-dose

Timeline

• Start date: 2023-08-07
• Primary completion: 2024-07-01
• Completion: 2024-07-01
• First posted: 2023-07-20
• Last updated: 2024-07-11

Locations

1 site across 1 country: China