Mass Balance Study Clinical Trial
Official title:
Mass Balance Study of [14C] D-1553 in Chinese Healthy Adult Male Subjects
- 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.
Primary Objectives: - 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 after a single oral dose of [14C] D-1553 in healthy subjects, 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 after a single oral dose of [14C] D-1553 in subjects, and obtain PK parameters of plasma TRA and investigate whole blood/plasma ratio for TRA. Secondary Objectives: - To observe the safety of a single oral dose of [14C] D-1553 in healthy subjects; - To quantitatively analyze the concentration of D-1553 and its metabolites (if applicable) in plasma using the validated LC-MS (liquid chromatography-mass spectrometry)/MS method and obtain the pharmacokinetic (PK) parameters of D-1553 and its metabolites (if applicable) in plasma. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02126514 -
A Phase I, Open-Label, Single-Center Study to Assess the Absorption, Metabolism, and Excretion of [14C]-AZD3293
|
Phase 1 |