Pharmacokinetics, Pharmacodynamics and Safety of SHR4640 in Patients With Hepatic Impairment

NCT04305392 | Unknown Phase 1

• 1 other identifier: SHR4640-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study to evaluate pharmacokinetics, pharmacodynamics and safety of SHR4640 in patients with mild, moderate hepatic impairment and normal liver function in phase I clinical study.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Peak Plasma Concentration (Cmax) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients

  72 hours after dosing

• Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞)

  Area under the plasma concentration versus time curve from single dosing time extrapolated to infinity (AUC0-∞) will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients

  72 hours after dosing

Study Arms (3)

Normal liver function

EXPERIMENTAL

Patients will receive single dose of SHR4640

Drug: SHR4640

Mild Hepatic Impairment

EXPERIMENTAL

Patients will receive single dose of SHR4640

Drug: SHR4640

Moderate Hepatic Impairment

EXPERIMENTAL

Patients will receive single dose of SHR4640

Drug: SHR4640

Interventions

SHR4640 DRUG

orally SHR4640

Mild Hepatic Impairment; Moderate Hepatic Impairment; Normal liver function

Eligibility Criteria

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

You may qualify if:

• All subjects:
• Signing the informed consent forms.
• years to 65 years (inclusive).
• Body mass index should be between 18 and 30 kg/m2 (inclusive).
• No medication was used before screening#or stable medication for 4 weeks.
• Normal liver function:
• Clinical laboratory tests during the screening period were normal or the abnormality has no clinical significance.
• Hepatic impaired subjects:
• Child-Pugh Classification score clinically determined as mild or moderate hepatic impairment.
• Liver damage due to primary liver disease.

You may not qualify if:

• All subjects:
• Subject known or suspected of being sensitive to the study drugs or its ingredient.
• Normal liver function:
• Previous history of liver function impairment, or physical examination and laboratory examination at screening indicated the presence or possibility of liver function impairment.
• Hepatitis B surface antigen (HBsAg) positive or Anti-hepatitis C virus (HCV) antibody or hepatitis C core antigen positive within 3 months prior to administration.
• Hepatic impaired subjects:
• Suspected or diagnosed as liver cancer or with other malignant tumors.
• Drug induced liver injury#acute liver injury#liver transplantation history.
• Subjects with hepatic failure,or severe complications caused by Hepatocirrhosis.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Meixia Wang

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Interventions

ruzinurad

Study Design

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

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 12, 2020
• Study Start: August 4, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

CN (1)