Pharmacokinetic/Pharmacokinetic and Safety Studies of SHR4640 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

NCT05954169 | Completed Phase 1

• 1 other identifier: SHR4640-111
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the pharmacokinetics, pharmacodynamics, and safety of SHR4640 tablets in subjects with moderate renal insufficiency and healthy subjects, and to explore the relationship between renal function (e.g., eGFR) and SHR4640 pharmacokinetic and pharmacodynamic parameters.

Conditions

Hyperuricemia

Outcome Measures

Primary Outcomes (3)

• PK parameters of SHR4640: Cmax

  0 hour to 72 hour after administration

• PK parameters of SHR4640: AUC0-t

  0 hour to 72 hour after administration

• PK parameters of SHR4640: AUC0-inf

  0 hour to 72 hour after administration

Secondary Outcomes (8)

• PK parameters of SHR4640: Tmax

  0 hour to 72 hour after administration

• PK parameters of SHR4640: t1/2

  0 hour to 72 hour after administration

• PK parameters of SHR4640: CL/F

  0 hour to 72 hour after administration

• PK parameters of SHR4640: Vz/F

  0 hour to 72 hour after administration

• Amount of SHR4640 excreted in urine (Ae0-72h)

  0 hour to 72 hour after administration

Study Arms (2)

Treatment group A in moderately renal insufficiency subjects

EXPERIMENTAL

Drug: SHR4640

Treatment group B in healthy subjects

EXPERIMENTAL

Drug: SHR4640

Interventions

SHR4640 DRUG

SHR4640 single-dose

Treatment group A in moderately renal insufficiency subjects; Treatment group B in healthy subjects

Eligibility Criteria

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

You may qualify if:

• Moderate renal impaired subjects:
• Able and willing to provide a written informed consent.
• years to 65 years (inclusive).
• Body mass index should be between 18 and 35 kg/m2 (inclusive).
• eGFR should be between 30 and 59 mL/min/1.73 m2 (inclusive).
• The renal function status is stable, and the results of two eGFR tests during the screening period (at least 3 days apart, but within 14 days) should be within ±25%.
• If subjects with underlying diseases required drug treatment, the dose needs to be kept stable during study.
• Healthy subjects:
• Able and willing to provide a written informed consent.
• years to 65 years (inclusive).
• Body mass index should be between 18 and 35 kg/m2 (inclusive).
• eGFR should be ≥ 90 and \< 130 mL/min/1.73 m2.
• The renal function status is stable, and the results of two eGFR tests during the screening period (at least 3 days apart, but within 14 days) should be within ±25%.

You may not qualify if:

• Moderate renal impaired subjects:
• Pregnant or nursing women.
• No birth control 2 weeks before screening or until one week after SHR4640 administration.
• Average daily alcohol consume more than 14g for female or more than 28g for male within 1 month before screening, or baseline alcohol screening is positive.
• Smokers (average daily smoking of 10 cigarettes or more in the 3 months before screening).
• Subject with a history of substance abuse and drug abuse.
• The investigators determined that other conditions were inappropriate for participation in this clinical trial.
• The investigators or relevant staff of the research centers or others directly involved in the study.
• weeks before SHR4640 administration sUA level ≥480 μmol/L.
• Alanine aminotransferase and/or aspartate aminotransferase\>2×ULN, alkaline phosphatase (ALP)\>2.5×ULN.
• Positive result for hepatitis B surface antigen.
• Positive result for human immunodeficiency virus (HIV), hepatitis C virus antibody or syphilis antibody.
• White blood cell \< 3.0×109/L, and/or hemoglobin \<80 g/L, and/or platelet \<80×109/L.
• lead electrocardiogram (ECG) showed abnormal and clinically significant.
• History of hypersensitivity to SHR4640 or its analogues.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 511447, China

Location

MeSH Terms

Conditions

Hyperuricemia

Interventions

ruzinurad

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

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

Model Details: Single-dose, open

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 20, 2023
• Study Start: August 7, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Locations

CN (1)