5
Clinical Trials associated with NTQ5082[14C]NTQ5082在中国健康受试者中的物质平衡研究
[Translation] [14C] NTQ5082 material balance study in Chinese healthy subjects
【主要研究目的】
(1) 定量分析男性健康受试者单次口服[14C] NTQ5082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) 定量分析男性健康受试者单次口服[14C] NTQ5082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NTQ5082在人体内的代谢途径及消除途径;
(3) 定量分析男性健康受试者单次口服[14C] NTQ5082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。
【次要研究目的】
(1) 采用已验证的液相色谱串联质谱联用法(LC-MS/MS)定量分析血浆中NTQ5082及其代谢产物(如适用)的浓度,进而评价血浆中NTQ5082及其代谢产物(如适用)的药代动力学参数;
(2) 观察[14C] NTQ5082单次给药后受试者的安全性。
[Translation] 【Main research objectives】
(1) To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C] NTQ5082, and obtain the data on the excretion rate of radioactivity in the human body and the main excretion pathway;
(2) To quantitatively analyze the radioactive metabolite profiles in human plasma, urine and feces after a single oral administration of [14C] NTQ5082 in male healthy subjects, identify the main metabolites, and determine the metabolic pathways and elimination pathways of NTQ5082 in the human body;
(3) To quantitatively analyze the total radioactivity in whole blood and plasma after a single oral administration of [14C] NTQ5082 in male healthy subjects, obtain the pharmacokinetic parameters of the total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of the total radioactivity in whole blood and plasma. 【Secondary study objectives】
(1) To quantitatively analyze the concentration of NTQ5082 and its metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and then evaluate the pharmacokinetic parameters of NTQ5082 and its metabolites (if applicable) in plasma;
(2) To observe the safety of subjects after a single dose of [14C] NTQ5082.
/ Not yet recruitingPhase 2 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Primary IgA Nephropathy
NTQ5082 is a small molecule inhibitor of complement factor B (CFB) that inhibits the enzymatic activity of CFB, thereby blocking the alternative pathway of the complement activation cascade. It is being clinically developed for the treatment of primary IgA nephropathy The main objectives of the study were to assess the efficacy and safety of NTQ5082 capsules in the treatment of patients with primary IgA nephropathy.
/ Not yet recruitingPhase 2 A Multicenter, Randomized, Open Label Phase II Clinical Trial Evaluating the Efficacy and Safety of NTQ5082 Capsules in the Treatment of Patients With Paroxysmal Nocturnal Hemoglobinuria
NTQ5082 capsule is a small molecule CFB factor inhibitor. This study is a multicenter, randomized, open label phase II clinical trial aimed at evaluating the efficacy, safety, and PK/PD characteristics of NTQ5082 capsules in the treatment of patients with paroxysmal nocturnal hemoglobinuria.
100 Clinical Results associated with NTQ5082
100 Translational Medicine associated with NTQ5082
100 Patents (Medical) associated with NTQ5082
100 Deals associated with NTQ5082