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

NCT ID: NCT03160014

Last Updated: 2017-05-19

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Hepatic Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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healthy volunteers

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

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

Mild Hepatic Impairment

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

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

Moderate Hepatic Impairment

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

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

Severe Hepatic Impairment

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

Group Type EXPERIMENTAL

SHR3824

Intervention Type DRUG

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

Interventions

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SHR3824

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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XiJing Hospital

XiAn, Shanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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XinMin Zhou

Role: CONTACT

029-84775507

Other Identifiers

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SHR3824-109

Identifier Type: -

Identifier Source: org_study_id

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