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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment
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Clinical Pharmacology of Delafloxacin in Patients With Hepatic Impairment

机译：肝损伤患者Delafloxacin的临床药理学

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Delafloxacin is a novel anionic fluoroquinolone with robust activity against Gram-positive, Gram-negative, atypical, and anaerobic bacteria, including methicillin-resistant S aureus. Delafloxacin is currently being studied for the treatment of acute bacterial skin and skin structure infections and community-acquired pneumonia. This was a phase 1, open-label pharmacokinetic and safety study of a single intravenous dose of 300 mg delafloxacin in subjects with mild, moderate, and severe hepatic impairment (Child-Pugh class A, B, and C, respectively) compared with matched healthy controls. The effects of hepatic impairment were assessed by ANOVA of log-transformed values for AUC(0-infinity), C-max, and systemic clearance, with hepatic group as a fixed effect. Mean AUC(0-infinity) and C-max in each impairment group were not significantly different from those of the pooled healthy subjects (rho > 0.05). The 90% confidence interval (CI) of the percentage ratios of least-squares means of AUC(0-infinity) did not indicate significant differences between the impairment groups and pooled healthy controls: Child-Pugh class A (mild) 114.4 (CI: 95.6, 137.0), Child-Pugh class B (moderate) 114.8 (CI: 95.9, 137.4), and Child-Pugh class C (severe) 115.1 (CI: 96.1, 137.8). A single IV infusion of delafloxacin was generally well tolerated in all treatment groups. The exposure and clearance of delafloxacin in subjects with mild, moderate, or severe hepatic impairment did not significantly differ from those of pooled, matched healthy subjects. Based on these pharmacokinetic data, dose adjustment of delafloxacin in the presence of hepatic impairment is not needed.
机译：Delafloxacin是一种新型阴离子氟喹诺酮，具有抗革兰氏阳性，革兰氏阴性，非典型和厌氧细菌的鲁棒活动，包括耐甲氧脲的金黄色葡萄球菌。目前正在研究Delafloxacin治疗急性细菌皮肤和皮肤结构感染和社区获得的肺炎。这是一个相1，开放标签药代动力学和安全性，对具有轻度，中度和严重的肝损伤（分别为匹配的儿童-space a，b和c）的受试者的单一静脉内剂量为300mg delafloxacin健康的控制。通过AUC（0-无穷大），C-MAX和全身间隙的对数转化值的ANOVA评估肝损伤的影响，具有肝组作为固定效果。每个损伤组中的平均AUC（0-无穷大）和C-MAX与合并的健康受试者的群体没有显着不同（RHO> 0.05）。 AUC（0-无穷大）最小二乘法百分比的90％置信区间（CI）没有表明损伤组和合并健康控制之间的显着差异：Child-Pugh课程A（MILD）114.4（CI： 95.6,137.0），Child-Pugh类B（中等）114.8（CI：95.9,137.4），儿童PUGH类C（严重）115.1（CI：96.1,137.8）。在所有治疗组中通常耐受Delafloxacin的单个IV输注。与轻度，中等或严重的肝障碍受试者的Delafloxacin的暴露和清除与合并的匹配的健康受试者没有显着差异。基于这些药代动力学数据，不需要在肝损伤存在下调整Delafloxacin。

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