NL-OMON30518已完成不适用
Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled). - TMC435350, SRD and MRD study (FIH)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy subjects aged between 18 and 55 years.
- •Non-smokers for at least 3 months prior to selection
- •Normal weight as defined by a BMI of 18.0 to 30.0 kg/m2. Normal 12-lead ECG
- •Subjects aged between 18 and 70 years, extremes included
- •Able to comply with protocol requirements and having good accessible veins.
- •Subjects with chronic Genotype 1 HCV infection, non-responders to previous treatment regimens (being interferon/ ribavirin or pegylated interferon/ribavirin)
排除标准
- •Past history of heart arrhythmias or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome or evidence of cardiomyopathy as evidenced by a grade 1 or higher decrease in EF/SF.
- •Female, except if postmenopausal since more than 2 years, or post-hysterectomy, or post tubal ligation.
- •Confirmed Hepatitis A, B, or C infection, or cancer or HIV/AIDS.
- •Participation in an investigational drug trial within 30 days prior to the first intake of trial medication.
- •Donation of blood or plasma within 60 days preceding the first intake of trial medication.
- •Subjects co-infected with HIV-1, HIV-2 or any hepatitis infection other than HCV.
- •Male subjects with female partners of childbearing potential not agreeing to use a reliable birth control method for 90 days after the last dosing in the study.
- •Subjects on non stable methadone use, on non stable anti-hypertensive treatment or on non stable antidepressant treatment.
研究者
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