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

NCT05032235 | Completed Phase 1

• 1 other identifier: SHR3162-I-119
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Impairment

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (5)

• Other pharmacokinetics parameters of Fluzoparib: Tmax

  96 hours post dose

• 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

Study Arms (3)

Group A

EXPERIMENTAL

Drug: Fluzoparib

Group B

EXPERIMENTAL

Drug: Fluzoparib

Group C

EXPERIMENTAL

Drug: Fluzoparib

Interventions

Fluzoparib DRUG

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

Group A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign the informed consent before the trial, and fully understand the content, process, and possible adverse reactions of the trial;
• Male or female subjects aged 18 to 70 (including 18 and 70);
• Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
• 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);
• 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.
• Sign the informed consent before the trial and fully understand the content, process, and possible adverse reactions of the trial;
• Male or female subjects aged 18 to 70 (including 18 and 70);
• Body mass index (BMI) ranges from 18 kg/m2 to 28 kg/m2 (including 18 and 28);
• Glomerular filtration rate (GFR) ≥90 mL/min.

You may not qualify if:

• History of kidney transplant;
• Need Renal dialysis during the study;
• Urinary incontinence or anuria;
• 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;
• Received any investigational drug within 3 months before the study started;
• Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
• Smokers and alcoholics, or those screened positive for alcohol;
• History of drug use, or drug abuse screening positive.
• History of kidney transplant;
• 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;
• Received any investigational drug within 3 months before the study started;
• Taking any drugs which can affect the metabolic enzyme CYP3A within 14 days before the study started;
• Smokers and alcoholics, or those screened positive for alcohol;
• History of drug use, or drug abuse screening positive.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The second affiliated hospital of Chongqing medical university

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

fluzoparib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single dose of oral administration of Fluzoparib

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: November 9, 2021
• Primary Completion: December 4, 2023
• Study Completion: December 5, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

CN (1)