A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)
2014年7月1日 更新者：Tibotec Pharmaceuticals, Ireland
An Open-label Trial in Genotype 2, 3, 4, 5 and 6 Hepatitis C-infected Subjects to Evaluate the Antiviral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 Following 7 Days Once Daily Dosing as Monotherapy.
The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435.
Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group).
The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication).
Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.
研究类型
介入性
注册 (实际的)
37
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participants with documented chronic genotype 2, 3, 4, 5 or 6 hepatitis C virus (HCV) infection
- Participants who have never received treatment for their HCV infection
- Participants with either no cirrhosis or up to Child Pugh A liver disease
- Participants with plasma HCV genotype level of more than or equal to 100, 000 IU/mL at screening
Exclusion Criteria:
- Evidence of Child Pugh B or C liver disease at screening, decompensated liver disease defined as prior or current history of ascities, hepatic encephalopathy, esophageal or gastric varices
- Participants with diagnosed or suspected hepatocellular carcinoma
- Participants coinfected with human immunodeficiency virus type 1 or 2, or hepatitis A or B virus infection or active tuberculosis at screening
- Participants with any active clinically significant disease, or medical history or physical examination or electrocardiogram findings during screening
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
|
实验性的：Genotype 3
Participants with chronic genotype 3 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
|
实验性的：Genotype 4
Participants with chronic genotype 4 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
|
实验性的：Genotype 5
Participants with chronic genotype 5 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
|
实验性的：Genotype 6
Participants with chronic genotype 6 HCV infection
|
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
大体时间：Baseline, Day 3, and Day 7
|
The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
|
Baseline, Day 3, and Day 7
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
大体时间：Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
|
|
Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
大体时间：Baseline, Day 3, Day 5 and Day 7
|
The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.
|
Baseline, Day 3, Day 5 and Day 7
|
|
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
大体时间：During the 7-day of TMC435 treatment period
|
The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.
|
During the 7-day of TMC435 treatment period
|
|
Predose Plasma Concentration (C0h) of TMC435
大体时间：Predose on Day 7
|
The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
|
Predose on Day 7
|
|
Minimum Plasma Concentration (Cmin) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Maximum Plasma Concentration (Cmax) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Average Steady-State Plasma Concentration (Css,av) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Fluctuation Index (FI) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Elimination Rate Constant of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
|
Terminal Elimination Half-life (t1/2,Term) of TMC435
大体时间：Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection.
The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.
|
Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年3月1日
初级完成 (实际的)
2009年11月1日
研究完成 (实际的)
2009年11月1日
研究注册日期
首次提交
2008年12月18日
首先提交符合 QC 标准的
2008年12月18日
首次发布 (估计)
2008年12月22日
研究记录更新
最后更新发布 (估计)
2014年7月28日
上次提交的符合 QC 标准的更新
2014年7月1日
最后验证
2014年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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