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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Normal Renal Function:A single oral dose of Fluzoparib will be administered.
Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.
Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.
The second affiliated hospital of Chongqing medical university
Chongqing, Chongqing Municipality, China
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
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)
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Time frame: 19 days