NCT05032235

Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function

A Multi-centre, Open-label and Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment. The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.

Conditions

• Renal Impairment

Interventions

Type	Name	Description
DRUG	Fluzoparib	Normal Renal Function:A single oral dose of Fluzoparib will be administered.
DRUG	Fluzoparib	Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.
DRUG	Fluzoparib	Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.

Timeline

• Start date: 2021-11-09
• Primary completion: 2023-12-04
• Completion: 2023-12-05
• First posted: 2021-09-02
• Last updated: 2024-01-19

Locations

1 site across 1 country: China