NCT04655872

Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects

A Phase I Study of the Mass Balance of a Single Oral Administration of [14C]TPN171H in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study is objective to evaluate the in vivo absorption, excretion and biotransformation pathways of \[14C\]-TPN171H in Chinese male healthy volunteers, and to reveal the overall pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational use of the drug.

Detailed description

This will be an open-label, single-center study to evaluate the mass-balance and pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral 10 mg dose of TPN171H containing approximately 100 microcuries of \[14C\]-TPN171H. Subjects will be checked in to the research unit from approximately 24 hours prior to dosing and remain in house until greater than 80% of the administered radioactivity is collected from bodily excreta or until less than 1% of the administered radioactivity is recovered from excreta in two consecutive time intervals, and blood sample radioactivity concentration at two consecutive time points less than 3 times the plasma background value. This study will investigate the main biotransformation and elimination pathways of TPN171H in the human body and will seek to identify compound's major metabolites.

Conditions

• Healthy Male Subjects

Interventions

Type	Name	Description
DRUG	[14C]TPN171H	A single 10 mg oral dose of \[14C\]TPN171H containing approximately 100 microcurie of \[14C\]-TPN171H.

Timeline

• Start date: 2020-11-26
• Primary completion: 2021-01-27
• Completion: 2021-01-27
• First posted: 2020-12-07
• Last updated: 2021-02-25

Locations

1 site across 1 country: China