Clinical trial NCT05032235: Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single dose of oral administration of Fluzoparib
Primary purpose: BASIC_SCIENCE

Brief 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.

The secondary objective is to evaluate the safety of Fluzoparib in subjects with mild and moderate renal impairment and in healthy subjects.


Eligibility criteria: Inclusion Criteria:

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Inclusion Criteria for subjects with impaired kidney function:

1. Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. 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);
5. 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:

1. Sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial;
2. Male or female subjects aged 18 to 70 (including 18 and 70);
3. Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
4. Glomerular filtration rate (GFR) ≥90 mL/min.

Exclusion Criteria:

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Exclusion Criteria for subjects with impaired kidney function:

1. History of kidney transplant;
2. Need Renal dialysis during the study;
3. Urinary incontinence or anuria;
4. 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;
5. Received any investigational drug within 3 months before the study started;
6. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
7. Smokers and alcoholics, or those screened positive for alcohol;
8. History of drug use, or drug abuse screening positive.

Exclusion Criteria for subjects with normal kidney function:

1. History of kidney transplant;
2. 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;
3. Received any investigational drug within 3 months before the study started;
4. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
5. Smokers and alcoholics, or those screened positive for alcohol;
6. History of drug use, or drug abuse screening positive.

Primary outcomes:
measure: Pharmacokinetics parameters of Fluzoparib: Cmax
timeFrame: 96 hours post dose
measure: Pharmacokinetics parameters of Fluzoparib: AUC0-t
timeFrame: 96 hours post dose
measure: Pharmacokinetics parameters of Fluzoparib: AUC0-∞ (if available)
timeFrame: 96 hours post dose
measure: Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Cmax
timeFrame: 96 hours post dose
measure: Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-t
timeFrame: 96 hours post dose
measure: Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-∞ (if available)
timeFrame: 96 hours post dose
Secondary outcomes:
measure: Other pharmacokinetics parameters of Fluzoparib: Tmax
timeFrame: 96 hours post dose
measure: Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax
timeFrame: 96 hours post dose
measure: Plasma protein binding rate of Fluzoparib
timeFrame: Day 01 post dose
measure: Plasma protein binding rate of main metabolite (SHR165202) of Fluzoparib
timeFrame: Day 01 post dose
measure: The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)
timeFrame: 19 days
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The second affiliated hospital of Chongqing medical university
state: Chongqing
Study officials:
References: