NCT05045313

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects

A Three-part, Single-center, Open-label, Phase I Clinical Study to Evaluate the Drug-drug Interactions (DDIs) Between DBPR108 and Warfarin Sodium/Digoxin/Probenecid in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a three-part, single-center, open-label phase I clinical study to characterize the DDIs potential of DBPR108 with Warfarin sodium, Digoxin, or Probenecid in healthy subjects. This study also aims to evaluate the safety and tolerability of DBPR108 in the presence of Warfarin sodium, Digoxin, or Probenecid.

Detailed description

DBPR108 is a potent dipeptidylpeptidase-4 inhibitor. This study will be run in three parts to characterize the DDIs potential of DBPR108 with the expected concomitant drugs (Warfarin sodium, Digoxin, Probenecid) in Healthy Subjects. Each part of this study consists of a screening period (Day -14 to Day -1), a baseline period (Day -1), a treatment period, and a follow-up visit period. Approximately 14 subjects will be enrolled in each part of this study.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Warfarin sodium tablets	Drug: Warfarin sodium, tablet, oral
DRUG	Digoxin tablet	Drug: Digoxin, tablet, oral
DRUG	Probenecid tablets	Drug: Probenecid, tablet, oral
DRUG	DBPR108 tablets	Drug: DBPR108, tablet, oral

Timeline

• Start date: 2021-10-20
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2021-09-16
• Last updated: 2022-03-10

Locations

1 site across 1 country: China