NCT04694365

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

A Open, Single-dose, Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to evaluate the safety and pharmacokinetics of Fluzoparib in subjects with impaired liver function in comparison with healthy subjects ,to develop dose recommendations for patients with hepatic impairment.

Conditions

• Hepatic Impairment
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Fluzoparib	A single oral dose of 50 mg Fluzoparib will be administered.

Timeline

• Start date: 2021-03-01
• Primary completion: 2024-06-19
• Completion: 2024-06-19
• First posted: 2021-01-05
• Last updated: 2025-04-30

Locations

1 site across 1 country: China