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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05032235
• Other study ID #: SHR3162-I-119
• Status: Completed
• Phase: Phase 1
• Start date: November 9, 2021
• Est. completion date: December 5, 2023

Study information

• Verified date: January 2024
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 5, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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:

-

Exclusion Criteria for subjects with impaired kidney function:

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.

Exclusion Criteria for subjects with normal kidney function:

1. History of kidney transplant;

2. 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;

3. Received any investigational drug within 3 months before the study started;

4. Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;

5. Smokers and alcoholics, or those screened positive for alcohol;

6. History of drug use, or drug abuse screening positive.

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• Fluzoparib
Normal Renal Function:A single oral dose of Fluzoparib will be administered.
• Fluzoparib
Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.
• Fluzoparib
Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.

Locations

Country	Name	City	State
China	The second affiliated hospital of Chongqing medical university	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics parameters of Fluzoparib: Cmax		96 hours post dose
Primary	Pharmacokinetics parameters of Fluzoparib: AUC0-t		96 hours post dose
Primary	Pharmacokinetics parameters of Fluzoparib: AUC0-8 (if available)		96 hours post dose
Primary	Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Cmax		96 hours post dose
Primary	Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-t		96 hours post dose
Primary	Pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: AUC0-8 (if available)		96 hours post dose
Secondary	Other pharmacokinetics parameters of Fluzoparib: Tmax		96 hours post dose
Secondary	Other pharmacokinetics parameters of main metabolite (SHR165202) of Fluzoparib: Tmax		96 hours post dose
Secondary	Plasma protein binding rate of Fluzoparib		Day 01 post dose
Secondary	Plasma protein binding rate of main metabolite (SHR165202) of Fluzoparib		Day 01 post dose
Secondary	The incidence and severity of adverse events/serious adverse events (based on NCI-CTCAE 5.0)		19 days