drugset / Trial / NCT06233916

Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects

NCT06233916

Phase 1 Completed 8 enrolled InventisBio Co., Ltd
NaSingle-groupOpen-labelHealth-services research

Summary

* To quantitatively analyze the total radioactivity (TRA) in excrement after a single oral dose of \[14C\] D-1553 in healthy subjects, and obtain radioactivity recovery and primary excretion pathways in humans; * To obtain radioactive metabolite profiles of human plasma, urine and feces , identify major metabolites of D-1553 and determine the major metabolic pathways and elimination pathways; * To quantitatively analyze the TRA in whole blood and plasma and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA.

Timeline

Start
2023-12-08
Primary completion
2024-01-03
Completion
2024-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject D-1553 Unknown 400 mg Oral

Indications

No indication recorded.