Renal ImpairmentPhase 1NCT05032235
Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
A Phase 1 study testing Fluzoparib in people with Renal Impairment, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Impairment
- 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
- 9 Nov 2021to 5 Dec 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- Inclusion Criteria for subjects with impaired kidney function:
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
- Male or female subjects aged 18 to 70 (including 18 and 70);
- Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
- The glomerular filtration rate should meet the following criteria (GFR, mL/min):Subjects with mild renal impairment (CKD2): 60-89 mL/min (including 60-89);Subjects with moderate renal impairment (CKD3): 30-59 mL/min (including 30-59 ends);
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- Renal function should be stable, and the GFR results should be tested twice before administration (at least 3 days apart) within the same CKD stage.
- Inclusion Criteria for subjects with normal kidney function:
- Sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial;
- Male or female subjects aged 18 to 70 (including 18 and 70);
- Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
- Glomerular filtration rate (GFR) ≥90 mL/min.
Who cannot join
- -
- Exclusion Criteria for subjects with impaired kidney function:
- History of kidney transplant;
- Need Renal dialysis during the study;
- Urinary incontinence or anuria;
- Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
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- Received any investigational drug within 3 months before the study started;
- Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
- Smokers and alcoholics, or those screened positive for alcohol;
- History of drug use, or drug abuse screening positive.
- Exclusion Criteria for subjects with normal kidney function:
- History of kidney transplant;
- Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
- Received any investigational drug within 3 months before the study started;
- Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
- Smokers and alcoholics, or those screened positive for alcohol;
- History of drug use, or drug abuse screening positive.
Trial locations and contacts
1 site in 1 country.
China1 site
The second affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, 400000
About this study
Official title: A Multi-centre, Open-label and Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.
- Conditions
- Renal Impairment
- Being tested
- Fluzoparib
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Normal Renal Function:A single oral dose of Fluzoparib will be administered.
FluzoparibDrug
Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.
FluzoparibDrug
Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Drug: Fluzoparib |
| Group B | Experimental | Not described Receives: Drug: Fluzoparib |
| Group C | 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: 96 hours post dose
Pharmacokinetics parameters of Fluzoparib: AUC0-t
Measured: 96 hours post dose
Pharmacokinetics parameters of Fluzoparib: AUC0-∞ (if available)
Measured: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Cmax
Measured: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-t
Measured: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-∞ (if available)
Measured: 96 hours post dose
Secondary outcomes (5)
Other pharmacokinetics parameters of Fluzoparib: Tmax
Measured: 96 hours post dose
Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax
Measured: 96 hours post dose
Plasma protein binding rate of Fluzoparib
Measured: Day 01 post dose
Plasma protein binding rate of main metabolite (SHR165202) of Fluzoparib
Measured: Day 01 post dose
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Measured: 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start9 Nov 2021
- Primary completion4 Dec 2023
- Study completion5 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal 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
- Model description
- Single dose of oral administration of Fluzoparib
- 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
- NCT05032235
- Sponsor's protocol ID
- SHR3162-I-119
- Status last verified
- Jan 2024
- First submitted
- 27 Aug 2021
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label and Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
- ClinicalTrials.gov ID
- NCT05032235
- Acronym / sponsor ID
- SHR3162-I-119
- Conditions
- Renal Impairment
- 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
- 9 Nov 2021 (actual)
- Primary completion
- 4 Dec 2023 (actual)
- Study completion
- 5 Dec 2023 (actual)
- First posted
- 2 Sep 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.
The primary objective is to evaluate pharmacokinetics of Fluzoparib and its main metabolite in subjects with impaired kidney function in comparison with healthy subjects, to develop dose recommendations for patients with renal impairment.
The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Single dose of oral administration of Fluzoparib
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Fluzoparib |
| Group B | Experimental | Drug: Fluzoparib |
| Group C | Experimental | Drug: Fluzoparib |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- -
- Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
- Male or female subjects aged 18 to 70 (including 18 and 70);
- Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
- The glomerular filtration rate should meet the following criteria (GFR, mL/min):Subjects with mild renal impairment (CKD2): 60-89 mL/min (including 60-89);Subjects with moderate renal impairment (CKD3): 30-59 mL/min (including 30-59 ends);
Key exclusion criteria (17 listed)
- -
- History of kidney transplant;
- Need Renal dialysis during the study;
- Urinary incontinence or anuria;
- Clinically significant heart disease, including but not limited to: congestive heart failure, symptomatic coronary artery disease, myocardial infarction, QTcF≥470 ms (female) or QTcF≥450 ms (male) within 12 months before the start of treatment;
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 |
|---|---|---|
| FluzoparibNormal Renal Function:A single oral dose of Fluzoparib will be administered. | Drug | Group A |
| FluzoparibMild Renal Impairment:A single oral dose of Fluzoparib will be administered. | Drug | Group B |
| FluzoparibModerate Renal Impairment:A single oral dose of Fluzoparib will be administered. | Drug | Group C |
Primary outcome
Pharmacokinetics parameters of Fluzoparib: Cmax
Time frame: 96 hours post dose
Pharmacokinetics parameters of Fluzoparib: AUC0-t
Time frame: 96 hours post dose
Pharmacokinetics parameters of Fluzoparib: AUC0-∞ (if available)
Time frame: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Cmax
Time frame: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-t
Time frame: 96 hours post dose
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-∞ (if available)
Time frame: 96 hours post dose
5 secondary outcomes
Other pharmacokinetics parameters of Fluzoparib: Tmax
Time frame: 96 hours post dose
Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax
Time frame: 96 hours post dose
Plasma protein binding rate of Fluzoparib
Time frame: Day 01 post dose
Plasma protein binding rate of main metabolite (SHR165202) of Fluzoparib
Time frame: Day 01 post dose
The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
Time frame: 19 days
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 19 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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 Renal Impairment, 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 12 inclusion and 17 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 19 Jan 2024. 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: 96 hours post dose). The study lists 6 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 19 Jan 2024.