NCT04859426

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	DBPR108 tablets	Drug: DBPR108, tablet, oral

Timeline

• Start date: 2021-06-09
• Primary completion: 2022-05-14
• Completion: 2022-05-17
• First posted: 2021-04-26
• Last updated: 2023-04-12

Locations

1 site across 1 country: China