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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Experimental |
| |
| Group C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluzoparib | Drug | Normal Renal Function:A single oral dose of Fluzoparib will be administered. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters of Fluzoparib: Cmax | 96 hours post dose | |
| Pharmacokinetics parameters of Fluzoparib: AUC0-t | 96 hours post dose | |
| Pharmacokinetics parameters of Fluzoparib: AUC0-∞ (if available) | 96 hours post dose | |
| Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Cmax | 96 hours post dose | |
| Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-t | 96 hours post dose | |
| Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-∞ (if available) | 96 hours post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Other pharmacokinetics parameters of Fluzoparib: Tmax | 96 hours post dose | |
| Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax | 96 hours post dose | |
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Inclusion Criteria:
-
Inclusion Criteria for subjects with impaired kidney function:
Inclusion Criteria for subjects with normal kidney function:
Exclusion Criteria:
-
Exclusion Criteria for subjects with impaired kidney function:
Exclusion Criteria for subjects with normal kidney function:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Chongqing medical university | Chongqing | Chongqing Municipality | 400000 | China |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000722917 | fluzoparib |
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Single dose of oral administration of Fluzoparib
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| Fluzoparib |
| Drug |
Mild Renal Impairment:A single oral dose of Fluzoparib will be administered. |
|
| Fluzoparib | Drug | Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered. |
|
| Plasma protein binding rate of Fluzoparib |
| Day 01 post dose |
| Plasma protein binding rate of main metabolite (SHR165202) of Fluzoparib | Day 01 post dose |
| The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0) | 19 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |