NCT05072028

Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]DBPR108 in Chinese Healthy Adult Male Subjects- Mass Balance and Biotransformation Study of [14C]DBPR108 in Human

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label phase I clinical study to evaluate the mass balance and biotransformation pathways of \[14C\]DBPR108 in Chinese healthy adult male subjects, to reveal the overall pharmacokinetic characteristics of DBPR108 in human body, and to provide a reference for the rational administration.

Detailed description

This study will evaluate the mass balance and pharmacokinetics of DBPR108 in approximately 6 healthy male subjects receiving a single oral 100 mg dose of DBPR108 containing approximately 150 µCi of \[14C\]- DBPR108. This study consists of a screening period (Day -7 to Day -2), a baseline period (Day -1), a treatment period, and a follow-up visit period.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	[14C]DBPR108	\[14C\]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral

Timeline

• Start date: 2021-11-16
• Primary completion: 2021-11-28
• Completion: 2021-11-28
• First posted: 2021-10-08
• Last updated: 2022-01-03

Locations

1 site across 1 country: China