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.

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects; Hepatic Impairment
• Intervention / Treatment: Drug: Fluzoparib

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China
      • Henan Infectious Diseases Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria for subjects with impaired liver function:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 65 (including 18 and 45) at the date of signing the informed consent;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 29kg /m2 (including 19 and 29);
5. Participants with alcoholic liver disease, autoimmune liver disease, Non-Alcoholic Liver Diseases and inherited metabolic liver disease. Mild Hepatic Impairment group should be stable≥28days ; Moderate Hepatic Impairment group should be stable≥14days.

Exclusion Criteria impaired liver function:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Received any surgery in the previous 6 months before screen phase;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal sysem.
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
7. Patients with hepatic encephalopathy;
8. Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,

Inclusion Criteria for subjects with normal liver function:

1. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
2. Ability to complete the study as required by the protocol;
3. Healthy male or female subjects aged 18 to 65 (including 18 and 45) at the date of signing the informed consent;The age and gender should match with impaired liver function;
4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 29kg /m2 (including 19 and 29); The body weight should match with impaired liver function.

Exclusion Criteria normal liver function:

1. Allergic constitution;
2. History of drug use, or drug abuse screening positive;
3. Alcoholic or often drinkers;
4. Received any surgery in the previous 6 months before screen phase;
5. A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal sysem.
6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases.
7. Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate Hepatic Impairment	Drug: Fluzoparib; A single oral dose of 50 mg Fluzoparib will be administered.
Experimental: Mild Hepatic Impairment	Drug: Fluzoparib; A single oral dose of 50 mg Fluzoparib will be administered.
Experimental: Normal Hepatic Function	Drug: Fluzoparib; A single oral dose of 50 mg Fluzoparib will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics parameters of Fluzoparib: Cmax	through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-t	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

Outcome Measure	Time Frame
Other pharmacokinetics parameters of Fluzoparib: Tmax	through study completion, an averange of half year
plasma protein binding rate of Fluzoparib	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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): June 19, 2024

Study Registration Dates

• First Submitted: December 28, 2020
• First Submitted That Met QC Criteria: January 3, 2021
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Poly(ADP-ribose) Polymerase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fluzoparib
• Other Study ID Numbers: SHR3162-I-117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No