drugset / Trial / NCT06233916
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-1553 | Unknown | 400 mg | Oral |
Indications
No indication recorded.