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

Phase 1

Completed

• Conditions: Hepatic Impairment; Healthy Subjects
• Interventions: Drug: Fluzoparib

• Registration Number: NCT04694365
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-28
• Study First Submitted QC: 2021-01-03
• Study First Posted: 2021-01-05
• Study Start: 2021-03-01
• Primary Completion: 2024-06-19
• Study Completion: 2024-06-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Hepatic Function	Fluzoparib	-
Moderate Hepatic Impairment	Fluzoparib	-
Mild Hepatic Impairment	Fluzoparib	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics parameters of Fluzoparib: AUC0-t	through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: Cmax	through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available)	through study completion, an averange of half year

Secondary Outcome Measures

Name	Time	Method
Other pharmacokinetics parameters of Fluzoparib: Tmax	through study completion, an averange of half year
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)	through study completion, an averange of half year
Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.	through study completion, an averange of half year
plasma protein binding rate of Fluzoparib	through study completion, an averange of half year

Trial Locations

Locations (1)

Henan Infectious Diseases Hospital; 🇨🇳 Zhengzhou, Henan, China