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

Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment (Single-Center, Open-label, Parallel-Group, Single-Dose Study)

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03160014

Enrollment

Registered

2017-05-19

Start date

2015-06-30

Completion date

2017-12-31

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Brief summary

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

Interventions

DRUGSHR3824

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* 18 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)

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
The area under the plasma concentration-time curve (AUC) of SHR3824	72 hours after dosing	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
The maximum plasma concentration (Cmax) of SHR3824	72 hours after dosing	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.

Secondary

Measure	Time frame	Description
The number of volunteers with adverse events as a measure of safety and tolerability	72 hours after dosing	The number of volunteers with adverse events as a measure of safety and tolerability

Countries

China

Contacts

Primary ContactXinMin Zhou

029-84775507

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026