NL-OMON41383已完成不适用
A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RG2459 IN HEALTHY VOLUNTEERS, INCLUDING A SINGLE DOSE PROOF-OF-CONCEPT PART IN PATIENTS INFECTED WITH HEPATITIS C VIRUS, AND A DRUG INTERACTION PART WITH SIMEPREVIR (TMC435) IN HEALTHY VOLUNTEERS - RG2459 SAD, MAD, DDI and POC study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
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
- •1.Males, or post-menopausal or hysterectomized females
- •2.Age:18 * 65 years, inclusive
- •3.BMI:18.0 * 30.0 kg/m2 ;Part D (SAD POC in HCV Patients)
- •1.Males, or post-menopausal or hysterectomized females;
- •2.Age:18 - 65 years, inclusive
- •3.BMI:18.0 * 38.0 kg/m2
- •4.Clinical and laboratory findings consistent with a clinical diagnosis of Chronic Hepatitis C
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60days before the start of this study or being a blood donor within 60 days from the start of the study. In case ofdonating more than 1.5 liters of blood in the 10 months prior the start of this study.;Part D:
- •Suffering from hepatitis B, cancer or HIV/AIDS. In case of participation in another drug study within
- •60days before the start of this study or being a blood donor within 60 days from the start of the study. In case ofdonating more than 1.5 liters of blood in the 10 months prior the start of this study.
研究者
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