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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 37
- 主要终点
- Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
研究概览
简要总结
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.
详细描述
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Genotype 4
Participants with chronic genotype 4 HCV infection
干预措施: TMC435 (Drug)
Genotype 2
Participants with chronic genotype 2 hepatitis C virus (HCV) infection
干预措施: TMC435 (Drug)
Genotype 3
Participants with chronic genotype 3 HCV infection
干预措施: TMC435 (Drug)
Genotype 5
Participants with chronic genotype 5 HCV infection
干预措施: TMC435 (Drug)
Genotype 6
Participants with chronic genotype 6 HCV infection
干预措施: TMC435 (Drug)
结局指标
主要结局
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
时间窗: 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.
次要结局
- 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(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(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7)
- Minimum Plasma Concentration (Cmin) of TMC435(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7)
- Fluctuation Index (FI) of TMC435(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on 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(Baseline, Day 3, Day 5 and Day 7)
- Elimination Rate Constant of TMC435(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7)
- 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(Baseline, Day 3, Day 5 and Day 7)
- Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period(During the 7-day of TMC435 treatment period)
- Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435(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(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7)
- Predose Plasma Concentration (C0h) of TMC435(Predose on Day 7)
- Maximum Plasma Concentration (Cmax) of TMC435(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(Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7)