* 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
8
\[14C\] D-1553 (approximately 400 mg/80 μCi)
beijing Gobroad Boren Hospital
Beijing, China
The radioactivity will be determined by a liquid scintillation counter. Analyze the total recovery (that is the ratio of the radioactivity in excrement samples to the radioactivity of the drug that administered ) in excrement
Recovery and cumulative recovery of total radioactive substance in excrement (urine and feces)
Time frame: 2 weeks
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
Exposure in plasma; percentage of unchanged drug and its metabolites in urine and feces to the administered dose; identification of major metabolites in plasma, urine and feces
Time frame: 2 weeks
whole blood/plasma ratio for TRA (total radioactivity) concentration at different time points
whole blood/plasma ratio for TRA concentration at different time points
Time frame: 2 weeks
Tmax (time to maximum observed concentration) parameters of TRA;
Tmax parameters of TRA in plasma
Time frame: baseline to 2 weeks
t1/2 (terminal elimination half-life) parameters of TRA;
t1/2 parameters of TRA in plasma
Time frame: baseline to 2 weeks
Cmax (maximum concentration) parameters of TRA;
Cmax parameters of TRA in plasma
Time frame: baseline to 2 weeks
MRT (mean residence time) parameters of TRA;
MRT parameters of TRA in plasma
Time frame: baseline to 2 weeks
AUC (area under curve) parameters of TRA;
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AUC parameters of TRA in plasma
Time frame: baseline to 2 weeks
Incidence and severity of AEs based on NCI CTCAE V5.0
Incidence and severity of adverse events (AEs) graded based on NCI CTCAE V5.0
Time frame: baseline to 3 weeks
Incidence and severity of SAEs based on NCI CTCAE V5.0
Incidence and severity of serious adverse events (SAEs) graded based on NCI CTCAE V5.0
Time frame: baseline to 3 weeks
Tmax parameters of D-1553 and its metabolites
Tmax parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
Cmax parameters of D-1553 and its metabolites
Cmax parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
AUC0-t parameters of D-1553 and its metabolites
AUC0-t parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
T1/2 parameters of D-1553 and its metabolites
T1/2 parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
MRT parameters of D-1553 and its metabolites
MRT parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
CL/F (apparent clearance) parameters of D-1553 and its metabolites
CL/F parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks
Vz/F (apparent volume of distribution) parameters of D-1553 and its metabolites
Vz/F parameters of D-1553 and its metabolites (if applicable) in plasma
Time frame: baseline to 2 weeks