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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

NCT04293029

Hepatic Impairment

COMPLETED PHASE1

An Investigational Study of SHR3680 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

NCT04631549

Hepatic Impairment Healthy Participants

UNKNOWN PHASE1

Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment

NCT03160014

Hepatic Impairment

UNKNOWN PHASE1

An Investigational Study of SHR6390 in Participants With Mild to Moderate Liver Impairment and Healthy Participants

NCT04631575

Hepatic Impairment Healthy Participants

UNKNOWN PHASE1

A Study to Compare Pharmacokinetic and Safety Profiles of Different Formulations of SHR-1314 After Subcutaneous Injection in Healthy Subjects

NCT04326881

Pharmacokinetic

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Normal liver function

Patients will receive single dose of SHR4640

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

orally SHR4640

Mild Hepatic Impairment

Patients will receive single dose of SHR4640

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

orally SHR4640

Moderate Hepatic Impairment

Patients will receive single dose of SHR4640

Group Type EXPERIMENTAL

SHR4640

Intervention Type DRUG

orally SHR4640

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR4640

orally SHR4640

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\-

All subjects:

* Signing the informed consent forms.
* 18 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.

Exclusion Criteria

\-

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes