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

A Multi-centre, Open-label and Parallel-control Study to Investigate the Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05032235

Enrollment

Registered

2021-09-02

Start date

2021-11-09

Completion date

2023-12-05

Last updated

2024-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Impairment

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.

Interventions

DRUGFluzoparib

Normal Renal Function:A single oral dose of Fluzoparib will be administered.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Single dose of oral administration of Fluzoparib

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

\- 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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-∞ (if available)	96 hours post dose
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

Secondary

Measure	Time frame
Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax	96 hours post dose
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
Other pharmacokinetics parameters of Fluzoparib: Tmax	96 hours post dose

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026