NCT05517616

The Absorption, Metabolism and Excretion of [14C]APG-2575 in Healthy Subjects

A Single-center, Open-label, Single-dose Phase 1 Clinical Study to Investigate the Absorption, Metabolism and Excretion of APG-2575 in Healthy Subjects After Oral Administration of 400 mg/200 µCi [14C] APG-2575 Solution

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The purpose of this study is to investigate the absorption properties, as well as to evaluate the mass balance and elucidate the pathways of biotransformation after a single oral dose of 400mg, 200μCi \[14C\] APG-2575 to healthy subjects.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	[14C ]APG-2575	orally, single dose of 400 mg / 200 μCi \[14C\] APG-2575

Timeline

• Start date: 2022-09-14
• Primary completion: 2022-11-01
• Completion: 2023-04-20
• First posted: 2022-08-26
• Last updated: 2024-01-23

Locations

1 site across 1 country: China