Pharmacokinetics, Safety, and Tolerability of TMC207 in Subjects With Moderately Impaired Hepatic Function

Tibotec BVBA0 个研究点目标入组 16 人开始时间: 2010年1月最近更新: 2012年12月20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: 16
主要终点: Area under curve from time of administration up to 72 hours post dosing of TMC207

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记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the pharmacokinetics (what the body does to the medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in healthy participants and in patients with moderate hepatic impairment after administration of a single 400 mg dose of TMC207.

详细描述

This is a Phase I, open label (all people know the identity of the intervention) study of TMC207. The study consists of a screening period and a 4-weeks treatment period. Sixteen participants will be enrolled in two panels. Panel A will include 8 patients of moderate hepatic impairment and Panel B will include 8 healthy participants. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study. The entire study duration for each participant will be approximately 7 weeks.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•For healthy participant Panel A: Healthy on the basis of physical examination, medical history, vital signs, electrocardiogram and clinical laboratory tests performed at screening
•Should match to a patient with hepatic impairment with regards to sex, age (more or less to 5 years), and body mass index
•For patients in Panel B with moderate hepatic impairment: history of hepatic disease, documented liver cirrhosis and moderate liver function impairment defined by the Child-Pugh classification

排除标准

•A positive tuberculin skin test indicating latent tuberculosis
•A positive human immunodeficiency virus (HIV)-1 or HIV-2 test at screening
•Moderate hepatic impairment patients with acute hepatitis, Hepatic carcinoma, Grade 3 or 4 encephalopathy, or active candidate for liver transplantation
•Matched healthy participants with current active hepatic disease

研究组 & 干预措施

Panel A

Experimental

8 patients with moderate hepatic impairment classified as moderate as per the Child Pugh Classification.

干预措施: TMC207 (Drug)

Panel B

Experimental

8 healthy participants who will match to patients with hepatic impairment in Panel A with regards to sex, age (more or less to 5 years), and body mass index.

干预措施: TMC207 (Drug)