临床试验/NCT00406237

NCT00406237已完成1 期

Open Label, Single Dose Study Of The Pharmacokinetics Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2006年12月最近更新: 2011年4月4日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 8
试验地点: 1
主要终点: To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Open label, single dose study of the pharmacokinetics of tigecycline in adult subjects with primary biliary cirrhosis (PBC)

详细描述

pharmacokinetic study

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Men and nonlactating and nonpregnant women greater than or equal to 18 years of age
•Subjects with biopsy proven primary biliary cirrhosis (PBC) disease in the asymptomatic or symptomatic phase of PBC.
•Otherwise healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results (other than those associated with PBC), vital signs, and 12-lead electrocardiogram (ECG).

排除标准

•Subjects with a recent increase in bilirubin, bilirubin >15 mg/dL, presence of ascites, esophageal varices, or hepatic encephalopathy.
•Any major illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in the study
•Any malignancy including hepatocellular carcinoma.

研究组 & 干预措施

1

Experimental

干预措施: tigecycline (Drug)

结局指标

主要结局

To assess the pharmacokinetics (PK) of tigecycline in subjects with cholestatic hepatic dysfunction.

时间窗: 5 days

次要结局

To assess the safety and tolerability of single doses of tigecycline in subjects with cholestatic hepatic dysfunction.(15 days)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

研究点 (1)

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