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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Metabolism, Excretion, and Pharmacokinetics of [C-14]-Cefiderocol (S-649266), a Siderophore Cephalosporin, in Healthy Subjects Following Intravenous Administration
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Metabolism, Excretion, and Pharmacokinetics of [C-14]-Cefiderocol (S-649266), a Siderophore Cephalosporin, in Healthy Subjects Following Intravenous Administration

机译：[C-14]的代谢，排泄和药代动力学 - COCINEROCOL（S-649266），一种静脉内给药后健康受试者的Sightophore头孢菌素（S-649266）

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摘要

The objectives of this study were to characterize the concentration-time profiles of total radioactivity equivalent and unchanged cefiderocol, the route(s) of elimination and mass balance, and safety of cefiderocol after intravenous administration of a single 1000-mg (100 mu Ci) dose of [C-14]-cefiderocol as a 1-hour infusion in healthy adult male subjects. Unchanged cefiderocol accounted for the majority of total radioactivity in plasma, and the partitioning of total radioactivity into red blood cells was negligible. The recovery of total radioactivity was complete in all subjects within 120 hours after initiation of the infusion (101.5% of the administered dose). Cefiderocol-related material was primarily excreted into urine, with 98.7% of the administered dose of [C-14]-cefiderocol excreted as total radioactivity into urine and negligible excretion into feces. Based on the results of metabolite profiling, cefiderocol accounted for 92.3% of area under the concentration-time curve of total radioactivity in plasma and accounted for 90.6% of the administered dose excreted into urine. Metabolism was a minor route of elimination for cefiderocol. Cefiderocol was generally safe and well tolerated in healthy adult male subjects. In conclusion, unchanged cefiderocol represents the majority of total radioactivity in plasma. Cefiderocol is primarily excreted as unchanged drug into urine. This study indicates that cefiderocol and drug-related material did not remain in the body.
机译：本研究的目的是表征总放射性等效和不变的小组的集中时间谱，消除和质量平衡的途径，以及静脉内施用单毫克1000mg（100μCI）后Cefiderocol的安全性[C-14]的剂量是在健康成年男性受试者中为1小时输注。没有改变的Cefideroon占血浆中总放射性的大部分，并且对红细胞的总放射性的分区可忽略不计。在输注开始后120小时内完成总放射性的总放射性恢复（101.5％的给药剂量）。将Colecolocol相关的材料主要排出尿液，98.7％的施用剂量的[C-14] -cefiderocol排泄到尿液中的总放射性，排泄到粪便中可忽略不计。基于代谢物分析的结果，Cefiderocol占血浆中总放射性的浓度 - 时间曲线下的92.3％，占90.6％的施用剂量排出尿液。新陈代谢是一个小的消除路径对cefiderocol。 Cefiderocol通常在健康的成年男性受试者中普遍安全且耐受良好。总之，不变的Cefiderocol代表了血浆中大部分放射性。 Cefiderocol主要排泄到尿液中的不变药物。本研究表明，身体上的小组和药物相关材料并不留在体内。

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