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

Inclusion criteria

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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);
• 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.

Exclusion criteria

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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;
• 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.