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A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment

Hepatic Impairment Clinical Trial

Official title:
An Open-label, Single-dose, Phase I Study to Assess the Pharmacokinetics and Safety of DBPR108 Tablets in Subjects With Mild, Moderate Hepatic Impairment Compared to the Control Subjects With Normal Hepatic Function

Clinical Trial Summary

This is an open-label, single-dose study to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function.

Clinical Trial Description

DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. The aim of this study is to evaluate the pharmacokinetics and safety of DBPR108 in subjects with mild or moderate hepatic impairment (HI) compared to the matched control subjects with normal hepatic function. This study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period (Day 1 to Day 3), and a follow-up call on Day 6. Subjects will be enrolled in the following groups: (A) mild hepatic impairment (Child-Pugh class A, 5-6 points); (B) moderate hepatic impairment (Child-Pugh class B, 7-9 points); (C) control subjects with normal hepatic function will be matched with subjects with HI by weight, age, and sex. Approximately 8 subjects will be enrolled in each group. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04859426
Study type Interventional
Source CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 9, 2021
Completion date May 17, 2022
View Details
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