Shandong Tefaman Pharmaceutical Co Ltd.

Main objectives: 1) Quantitative analysis of the total radioactivity in excreta after a single oral administration of [14C]TPN729MA to healthy male subjects, and to obtain the cumulative excretion rate and main excretion pathway of radioactivity in humans; 2) To investigate the distribution of [14C]TPN729MA in whole blood and plasma and the pharmacokinetic characteristics of total radioactivity in plasma after a single oral administration of [14C]TPN729MA to healthy male subjects; 3) To evaluate the main metabolites in plasma, urine and feces of healthy male subjects after a single oral administration of [14C]TPN729MA, and to determine the main biotransformation pathways and main metabolites (close to or >10% of the total radioactivity AUC). Secondary objectives: 1) To quantitatively analyze TPN729MA and major metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and to obtain the corresponding pharmacokinetic parameters; 2) To evaluate the safety of [14C]TPN729MA after a single oral administration of [14C]TPN729MA to healthy male subjects.

Primary objective: To evaluate the pharmacokinetic characteristics of unchanged TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of hepatic insufficiency and healthy subjects after a single dose. Secondary objectives: (1) To evaluate the safety of unchanged TPN729MA tablets in male subjects with different degrees of hepatic insufficiency and healthy subjects after a single dose. (2) To evaluate the plasma protein binding rate of unchanged TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of hepatic insufficiency and healthy subjects after a single dose.

Primary objective: To evaluate the pharmacokinetic characteristics of the original TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose. Secondary objectives: 1) To evaluate the safety of TPN729MA tablets in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose; 2) To evaluate the plasma protein binding rate of the original TPN729MA tablets and its metabolite TPN-M3 in male subjects with different degrees of renal insufficiency and healthy subjects after a single dose.