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CompletedNCT04694365Updated Apr 30, 2025

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

A Phase 1 interventional study of Fluzoparib in Hepatic Impairment and Healthy Subjects, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-30.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatic Impairment
  • Healthy Subjects
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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,
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Normal Hepatic Function

    Drug: Fluzoparib

  • Experimental
    Mild Hepatic Impairment

    Drug: Fluzoparib

  • Experimental
    Moderate Hepatic Impairment

    Drug: Fluzoparib

Interventions

  • DrugFluzoparib

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

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics parameters of Fluzoparib: Cmax

    Time frame: through study completion, an averange of half year

  2. Pharmacokinetics parameters of Fluzoparib: AUC0-t

    Time frame: through study completion, an averange of half year

  3. Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available)

    Time frame: through study completion, an averange of half year

Secondary outcomes

  1. Other pharmacokinetics parameters of Fluzoparib: Tmax

    Time frame: through study completion, an averange of half year

  2. plasma protein binding rate of Fluzoparib

    Time frame: through study completion, an averange of half year

  3. The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)

    Time frame: through study completion, an averange of half year

  4. Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.

    Time frame: through study completion, an averange of half year

07

Study locations

1 site
  • Henan Infectious Diseases Hospital
    Zhengzhou, Henan, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04694365
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jan 5, 2021
Start date
Mar 1, 2021
Primary completion
Jun 19, 2024
Completion
Jun 19, 2024
Last update
Apr 30, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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