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Clinical Trials associated with HS-10365[14C]HS-10365在中国成年健康男性受试者体内的物质平衡研究
[Translation] Study on the material balance of [14C]HS-10365 in healthy adult male subjects in China
本试验旨在评价中国男性健康受试者单剂量口服[14C]HS-10365 的物质平衡及代谢途径,揭示 HS-10365 在人体内的药代动力学整体特征,为药物的合理使用提供参考。
主要目的:1. 定量分析受试者口服[14C]HS-10365 后排泄物中的总放射性,获得人体放射性排泄率数据和主要排泄途径。2. 获得受试者口服[14C]HS-10365 后血浆、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。
3. 定量分析受试者单次口服[14C]HS-10365 后全血和血浆中的总放射性,获得全血和血浆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。
次要目的:1. 采用已验证的 LC-MS/MS 方法定量分析血浆中 HS-10365 和代谢产物(如适用)的浓度,获得血浆中 HS-10365 和代谢产物(如适用)的药代动力学参数。2. 观察[14C]HS-10365 单次给药后受试者的安全性。
[Translation] This study aims to evaluate the material balance and metabolic pathways of [14C]HS-10365 after a single oral dose in healthy Chinese male subjects, reveal the overall pharmacokinetic characteristics of HS-10365 in humans, and provide a reference for the rational use of drugs.
Main objectives: 1. Quantitatively analyze the total radioactivity in the excreta of subjects after oral administration of [14C]HS-10365, and obtain data on human radioactive excretion rate and main excretion pathways. 2. Obtain the radioactive metabolite spectrum of plasma, urine and feces of subjects after oral administration of [14C]HS-10365, identify the main metabolites, determine the metabolic pathways and elimination pathways.
3. Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral administration of [14C]HS-10365, obtain the pharmacokinetic parameters of total radioactivity in whole blood and plasma, and investigate the distribution of total radioactivity in whole blood and plasma.
Secondary objectives: 1. To quantitatively analyze the concentrations of HS-10365 and metabolites (if applicable) in plasma using a validated LC-MS/MS method and obtain the pharmacokinetic parameters of HS-10365 and metabolites (if applicable) in plasma. 2. To observe the safety of subjects after a single dose of [14C]HS-10365.
A Phase II, Open-label, Multicenter Study to Evaluate the Efficacy,Safety and Pharmacokinetics of HS-10365 as First-Line Treatment for Patients With Locally Advanced or Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
HS-10365 is a small molecular, oral potent, selective RET inhibitor. The purpose of this study is to investigate the efficacy and safety of HS-10365 in Chinese advanced RET fusion-positive non-small cell lung cancer patients without any systemic therapy.
HS-10365在健康受试者中的耐受性、安全性和药动学特征研究
[Translation] Study on the tolerability, safety and pharmacokinetic characteristics of HS-10365 in healthy subjects
主要研究目的:评价健康受试者口服 HS-10365 后的安全性和耐受性。
次要研究目的:获得健康受试者服用 HS-10365 后的药代动力学特征。
[Translation] Primary study objective: To evaluate the safety and tolerability of HS-10365 after oral administration in healthy subjects.
Secondary study objective: To obtain the pharmacokinetic characteristics of HS-10365 after administration in healthy subjects.
100 Clinical Results associated with HS-10365
100 Translational Medicine associated with HS-10365
100 Patents (Medical) associated with HS-10365
100 Deals associated with HS-10365