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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date16 Nov 2011 |
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Drug Highest PhaseNDA/BLA |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Inactive Indication- |
Drug Highest PhasePhase 2/3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingNot ApplicableIIT A single-center, randomized, open-label, two-period, two-sequence crossover clinical study to evaluate the effect of food on the pharmacokinetic characteristics of CMS-D001 tablets in healthy participants.
[14C] CMS-D001在中国健康成年男性参与者中的物质平衡研究
[Translation] [14C] CMS-D001 Material Balance Study in Healthy Adult Male Participants in China
主要目的:
1.定量分析健康男性参与者口服[14C] CMS-D001后排泄物中的总放射性,获得人体放射性回收率和主要排泄途径;
2.考察健康男性参与者口服[14C] CMS-D001后全血与血浆总放射性的分配比,以及全血(如适用)和血浆中总放射性的药代动力学特征;
3.获得健康男性参与者口服[14C] CMS-D001后血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定主要生物转化途径。
次要目的:
1.采用已验证的LC-MS/MS方法定量分析血浆中CMS-D001、代谢物M414-2及其它主要代谢产物(如适用)的浓度,获得血浆中CMS-D001、M414-2及其它主要代谢产物(如适用)的药代动力学参数;
2.观察中国健康成年男性参与者单次口服[14C] CMS-D001后的安全性。
[Translation] Main objectives:
1. To quantitatively analyze the total radioactivity in the excrement of healthy male participants after oral administration of [14C] CMS-D001, and to obtain the human radioactivity recovery rate and main excretion pathway;
2. To investigate the partition ratio of total radioactivity in whole blood and plasma after oral administration of [14C] CMS-D001 in healthy male participants, and the pharmacokinetic characteristics of total radioactivity in whole blood (if applicable) and plasma;
3. To obtain the radiometabolite profiles of plasma, urine, and feces after oral administration of [14C] CMS-D001 in healthy male participants, identify the major metabolites, and determine the main biotransformation pathways. Secondary objectives: 1. To quantitatively analyze the plasma concentrations of CMS-D001, metabolite M414-2, and other major metabolites (if applicable) using a validated LC-MS/MS method, and to obtain the pharmacokinetic parameters of CMS-D001, M414-2, and other major metabolites (if applicable) in plasma;
2. To observe the safety of a single oral administration of [14C] CMS-D001 to healthy adult male participants in China.
/ Not yet recruitingPhase 2/3IIT A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of CMS-D001 Tablets in Adult Patients with Moderate to Severe Plaque Psoriasis.
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