Shenzhen Haibin Pharmaceutical Co., Ltd.

This study aims to evaluate the pharmacokinetic characteristics of JKN2306 tablets in participants with mild to moderate hepatic impairment and to compare them with those in participants with normal hepatic function, providing a scientific basis for rational clinical use of the drug in participants with hepatic impairment.

Main objectives: (1) To quantitatively analyze the total radioactivity in the excrement of healthy male participants after a single oral administration of [14C]JKN2306, and to obtain data on human radioactivity recovery rate and main excretion pathways; (2) To obtain the radiometabolite profiles in plasma, urine, and feces of healthy male participants after a single oral administration of [14C]JKN2306, and to determine the main biotransformation pathways and main metabolites (approximately or greater than 10% of the total radioactivity AUC); (3) To quantitatively analyze the total radioactivity in whole blood and plasma of healthy male participants after a single oral administration of [14C]JKN2306, to obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and to investigate the distribution of total radioactivity in whole blood and plasma. Secondary objectives: (1) To quantitatively analyze the concentrations of JKN2306 and its metabolites (if applicable) in plasma using validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) and obtain the pharmacokinetic parameters of JKN2306 and its metabolites (if applicable) in plasma; (2) To observe the safety of a single oral dose of [14C]JKN2306 in healthy male participants. Exploratory objectives: (1) To assess the elimination contribution of JKN2306 through various elimination pathways.

To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of a single oral administration of the OATP1B1 substrate pravastatin. To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of a single oral administration of the CYP2B6 substrate bupropion. To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of hydroxybupropion, the major active metabolite produced after a single oral administration of bupropion.