[Translation] [14C]-MI078 Single-center, open-label, non-randomized, single-dose mass balance study in healthy adult male participants.
主要目的:考察健康成年男性研究参与者单次口服给予[14C]-MI078 后,尿液和粪便中总放射性,获得人体放射性回收率和主要排泄途径;分析研究参与者单次口服 [14C]-MI078 后全血和血浆中的总放射性,获得血浆和全血(如适用)总放射性的药代动力学参数,并考察全血和血浆中总放射性的分配情况;获得研究参与者口服[14C]-MI078 后人血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定代谢途径及消除途径。
次要目的:采用液相色谱串联质谱联用法(LC-MS/MS)定量分析血浆中MI078、代谢物MI001 及其他代谢产物(如适用)的浓度,进而评价血浆中MI078、代谢物MI001 及其他代谢产物(如适用)的药代动力学参数;评价[14C]-MI078 单次口服给药后在健康成年男性研究参与者的安全性和耐受性。
[Translation] Main objectives: To investigate the total radioactivity in urine and feces of healthy adult male participants after a single oral administration of [14C]-MI078, to obtain the human radioactivity recovery rate and major excretion pathway; to analyze the total radioactivity in whole blood and plasma of participants after a single oral administration of [14C]-MI078, to obtain the pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and to investigate the distribution of total radioactivity in whole blood and plasma; to obtain the radiometabolite profiles of human plasma, urine, and feces after oral administration of [14C]-MI078, to identify major metabolites, and to determine metabolic and elimination pathways.
Secondary objective: To quantitatively analyze the concentrations of MI078, metabolite MI001, and other metabolites (if applicable) in plasma using liquid chromatography-tandem mass spectrometry (LC-MS/MS), and to evaluate the pharmacokinetic parameters of MI078, metabolite MI001, and other metabolites (if applicable) in plasma; and to evaluate the safety and tolerability of a single oral dose of [14C]-MI078 in healthy adult male study participants.