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

NCT04694365 | Completed Phase 1

• 1 other identifier: SHR3162-I-117
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Impairment; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (3)

Normal Hepatic Function

EXPERIMENTAL

Drug: Fluzoparib

Mild Hepatic Impairment

EXPERIMENTAL

Drug: Fluzoparib

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: Fluzoparib

Interventions

Fluzoparib DRUG

A single oral dose of 50 mg Fluzoparib will be administered.

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• Healthy male or female subjects aged 18 to 65 (including 18 and 45) at the date of signing the informed consent;
• 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);
• 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.

You may not qualify if:

• Allergic constitution;
• History of drug use, or drug abuse screening positive;
• Alcoholic or often drinkers;
• Received any surgery in the previous 6 months before screen phase;
• 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.
• 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.
• Patients with hepatic encephalopathy;
• Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,
• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Ability to complete the study as required by the protocol;
• 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;
• 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.
• Allergic constitution;
• History of drug use, or drug abuse screening positive;
• Alcoholic or often drinkers;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Henan Infectious Diseases Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

fluzoparib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 5, 2021
• Study Start: March 1, 2021
• Primary Completion: June 19, 2024
• Study Completion: June 19, 2024
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (1)