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COMPLETEDPHASE1

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

NCT05032235•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•\-
•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.
•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

•\-
•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.
•1. History of kidney transplant;
+5 more criteria

Locations (1)

The second affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

November 9, 2021

Primary Completion Date

December 4, 2023

Completion Date

December 5, 2023

Last Updated

January 19, 2024

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

Fluzoparib

DRUG

Fluzoparib

DRUG

Fluzoparib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure