Hepatic ImpairmentPhase 1NCT04694365
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function
A Phase 1 study testing Fluzoparib in people with Hepatic Impairment and Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Subjects
- What is being tested?
- Fluzoparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 19 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Patients with hepatic encephalopathy;
- Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,
- 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.
- Taking any drugs which affects the metabolic enzyme CYP3A within 14 days before the study started,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hepatic Impairment, Healthy Subjects
- Being tested
- Fluzoparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
A single oral dose of 50 mg Fluzoparib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Normal Hepatic Function | Experimental | Not described Receives: Drug: Fluzoparib |
| Mild Hepatic Impairment | Experimental | Not described Receives: Drug: Fluzoparib |
| Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameters of Fluzoparib: Cmax
Measured: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-t
Measured: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available)
Measured: through study completion, an averange of half year
Secondary outcomes (4)
Other pharmacokinetics parameters of Fluzoparib: Tmax
Measured: through study completion, an averange of half year
plasma protein binding rate of Fluzoparib
Measured: through study completion, an averange of half year
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Measured: through study completion, an averange of half year
Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.
Measured: through study completion, an averange of half year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Mar 2021
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694365
- Sponsor's protocol ID
- SHR3162-I-117
- Status last verified
- Apr 2025
- First submitted
- 28 Dec 2020
- Last updated
- 30 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open, Single-dose, Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function.
- ClinicalTrials.gov ID
- NCT04694365
- Acronym / sponsor ID
- SHR3162-I-117
- Conditions
- Hepatic Impairment, Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Hepatic Function | Experimental | Drug: Fluzoparib |
| Mild Hepatic Impairment | Experimental | Drug: Fluzoparib |
| Moderate Hepatic Impairment | Experimental | Drug: Fluzoparib |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FluzoparibA single oral dose of 50 mg Fluzoparib will be administered. | Drug | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function |
Primary outcome
Pharmacokinetics parameters of Fluzoparib: Cmax
Time frame: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-t
Time frame: through study completion, an averange of half year
Pharmacokinetics parameters of Fluzoparib: AUC0-∞(if available)
Time frame: through study completion, an averange of half year
4 secondary outcomes
Other pharmacokinetics parameters of Fluzoparib: Tmax
Time frame: through study completion, an averange of half year
plasma protein binding rate of Fluzoparib
Time frame: through study completion, an averange of half year
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
Other pharmacokinetics parameters of Fluzoparib: T1/2 etc.
Time frame: through study completion, an averange of half year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluzoparib in people with Hepatic Impairment and Healthy Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics parameters of Fluzoparib: Cmax (time frame: through study completion, an averange of half year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.