Pharmacokinetics and Safety of SHR0302 in Patients With Hepatic Impairment

NCT04293029 | Completed Phase 1

• 1 other identifier: SHR0302-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Evaluate Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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

• Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t）

  Area under the plasma concentration versus time curve from the last time of dosing to the last measurable concentration （AUC0-t） will be compared between normal hepatic function patients and mild or moderate hepatic dysfunction patients

  72 hours after dosing

Secondary Outcomes (1)

• Adverse events

  72 hours after dosing

Study Arms (3)

Normal liver function

EXPERIMENTAL

Patients will receive single dose of SHR0302

Drug: SHR0302

Mild Hepatic Impairment

EXPERIMENTAL

Patients will receive single dose of SHR0302

Drug: SHR0302

Moderate Hepatic Impairment

EXPERIMENTAL

Patients will receive single dose of SHR0302

Drug: SHR0302

Interventions

SHR0302 DRUG

SHR0302

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)

The First Affiliated Hospital of Jilin University

Changchun, Jilin, China

Location

MeSH Terms

Interventions

ivarmacitinib

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: February 28, 2020
• First Posted: March 3, 2020
• Study Start: May 20, 2020
• Primary Completion: December 27, 2020
• Study Completion: December 30, 2020
• Last Updated: October 14, 2021

Record last verified: 2020-02

Locations

CN (1)