NCT06671873

Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects

A Single-center, Open-label, Single-dose Phase I Clinical Study to Investigate the Human Mass Balance in Healthy Chinese Adult Male Subjects Following a Single Oral Dose of 250 mg/100 µCi [14C] HMPL-306

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hutchmed · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HMPL-306

Detailed description

* To quantitatively analyze the total radioactivity in excreta after oral administration of \[14C\]HMPL-306 in healthy subjects, obtain the data on human radioactivity excretion rate and determine the main excretion pathways; * To obtain the radioactive metabolite profile in plasma, urine, and feces after oral administration of \[14C\]HMPL-306 in healthy subjects, to identify the main metabolites and to determine the metabolism and elimination pathways; * To quantitatively analyze the total radioactivity in whole blood and plasma in healthy subjects after oral administration of \[14C\]HMPL-306, to obtain the pharmacokinetics of total radioactivity in plasma and to investigate the distribution of total radioactivity in whole blood and plasma;

Conditions

• Mass Balance Study

Interventions

Type	Name	Description
DRUG	100 µCi [14C] HMPL-306	D1: 250 mg/100 µCi \[14C\] HMPL-306 Single dose

Timeline

• Start date: 2024-11-26
• Primary completion: 2025-02-28
• Completion: 2025-07-02
• First posted: 2024-11-04
• Last updated: 2025-07-31

Locations

1 site across 1 country: China