Beijing Tiancheng Pharmaceutical Technology Co Ltd

【Main research objectives】 1. To quantitatively analyze the total radioactivity in excreta after a single oral administration of [14C]ICP-192 to healthy subjects, obtain data on human radioactive excretion rate, and study the main excretion pathways; 2. To quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C]ICP-192 to healthy subjects, obtain pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and investigate the distribution in whole blood and plasma; 3. To identify the main metabolites in plasma, urine, and feces after a single oral administration of [14C]ICP-192 to healthy subjects, and determine the metabolic pathways and elimination pathways of ICP-192 in the human body. 【Secondary study objectives】 1. To quantitatively analyze the concentration of ICP-192 and its metabolites (if applicable) in plasma using a validated LC-MS/MS method and obtain the pharmacokinetic characteristics of ICP-192 and its metabolites (if applicable) in plasma; 2. To evaluate the safety of [14C]ICP-192 in healthy subjects after a single dose.

1. Primary objective: To evaluate the effect of a high-fat diet on the pharmacokinetic (PK) characteristics of ICP-192 tablets after a single oral administration in healthy Chinese subjects. 2. Secondary objective: To evaluate the safety and tolerability of ICP-192 tablets in healthy Chinese subjects. 3. Other objectives: To evaluate the effect of fasting ICP-192 on the QTc interval in healthy subjects.

To evaluate the objective response rate (ORR) of ICP-192 tablets in subjects with unresectable or metastatic intrahepatic cholangiocarcinoma with FGFR2 fusion/rearrangement who have failed previous treatment