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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.
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8 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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