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

NCT03160014 | Unknown Phase 1

• 1 other identifier: SHR3824-109
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.

Conditions

Hepatic Impairment

Outcome Measures

Primary Outcomes (2)

• The area under the plasma concentration-time curve (AUC) of SHR3824

  AUC (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients

  72 hours after dosing

• The maximum plasma concentration (Cmax) of SHR3824

  Cmax (a measure of the body's exposure to SHR3824) will be compared between normal hepatic function patients and mild or moderate or severe hepatic dysfunction patients.

  72 hours after dosing

Secondary Outcomes (1)

• The number of volunteers with adverse events as a measure of safety and tolerability

  72 hours after dosing

Study Arms (4)

healthy volunteers

EXPERIMENTAL

Drug: SHR3824 20mg/day, oral tablet, single dose

Drug: SHR3824

Mild Hepatic Impairment

EXPERIMENTAL

Drug: SHR3824 20mg/day, oral tablet, single dose

Drug: SHR3824

Moderate Hepatic Impairment

EXPERIMENTAL

Drug: SHR3824 20mg/day, oral tablet, single dose

Drug: SHR3824

Severe Hepatic Impairment

EXPERIMENTAL

Drug: SHR3824 20mg/day, oral tablet, single dose

Drug: SHR3824

Interventions

SHR3824 DRUG

Drug: SHR3824 20mg/day, oral tablet, single dose

Mild Hepatic Impairment; Moderate Hepatic Impairment; Severe Hepatic Impairment; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 75 years (inclusive)
• Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
• Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)

You may not qualify if:

• allergic to SGLT2 inhibitor analogues or any other similar structure;
• lactose intolerance history or lactose intolerance;
• Suspected or diagnosed as liver cancer or with other malignant tumors;
• Alcoholic liver, autoimmune liver disease, liver transplantation history

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

XiJing Hospital

XiAn, Shanxi, 710032, China

RECRUITING

MeSH Terms

Interventions

henagliflozin

Central Study Contacts

XinMin Zhou

CONTACT

029-84775507

Study Design

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

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 19, 2017
• Study Start: June 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 19, 2017

Record last verified: 2016-06

Locations

CN (1)