ISRCTN80501908已完成不适用
A phase I/IIa study assessing single and multiple doses of hepatitis C virus (HCV) non-nucleoside polymerase inhibitor IDX375 in healthy and genotype 1 HCV-infected subjects
Idenix Pharmaceuticals, Inc. (USA)0 个研究点目标入组 78 人开始时间: 2010年8月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
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
- 性别
- All
入选标准
- •All participants:
- •1. Aged 18 - 65 years
- •2. Body mass index (BMI) 18 - 35 kg/m^2
- •3. Must agree to use an acceptable double-barrier method of birth control
- •4. Male subject must agree not to donate sperm for 90 days after the last dose of study drug
- •5. Subject has provided written informed consent to participate in the study
- •Specific to healthy subjects:
- •6. Subject must be male
- •7. Subject must be a non-smoker
- •Specific to HCV-infected subjects:
- •8. Female subjects must be of non-childbearing potential
- •9. Documented clinical history compatible with chronic hepatitis C
- •10. Plasma HCV ribonucleic acid (RNA) greater than or equal to 5 log10 IU/mL at screening
- •11. HCV genotype 1
- •12. HCV treatment-naive
排除标准
- •All participants:
- •1. Co-infected with hepatitis B virus and/or human immunodeficiency virus (HIV)
- •2. Donated blood or had significant blood loss 60 days prior to dosing
- •3. Use of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the Investigator
- •4. Use of other investigational drugs within 60 days of dosing, or plans to enrol in another clinical trial of an investigational agent while participating in the present study
- •5. Subject with known allergy to the study medication or any of its components
- •6. Clinically significant laboratory or electrocardiogram (ECG) abnormalities
- •7. Any clinically significant medical condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results
- •Specific to healthy subjects:
- •8. Concomitant use of prescription medications or systemic over-the-counter (OTC) medications. A washout period of at least 5 half-lives must be observed prior to study drug dosing, if the Investigator feels that the medication can be safely discontinued for the duration of the study.
- •9. Positive screen for anti-HCV antibody
- •Specific to HCV-infected subjects:
- •10. Subject is pregnant or breastfeeding
- •11. History or signs of decompensated liver disease: Child-Pugh class B or C, ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
- •12. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
研究者
相似试验
已完成
不适用
Safety and clinical effects of IDX320 in Hepatitis C infectioGenotype 1 Chronic Hepatitis CInfections and InfestationsChronic viral hepatitisISRCTN44746369Idenix Pharmaceuticals (USA)88
进行中（未招募）
1 期
A first-in-human trial of IDX21437, a new study drug being evaluated for hepatitis C virus infection.Hepatitis C virusMedDRA version: 16.1Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848EUCTR2013-004043-23-BEIdenix Pharmaceuticals Inc.
进行中（未招募）
不适用
A Phase I/IIa Study Assessing Single and Multiple Doses of HCV Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected SubjectsHealthy Volunteers and Genotype 1 HCV infectionMedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis CEUCTR2009-018079-15-HUIdenix Pharmaceuticals, Inc84
进行中（未招募）
不适用
A Phase I/IIa Study Assessing Single and Multiple Doses of HCV Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected SubjectsEUCTR2009-018079-15-PLIdenix Pharmaceuticals, Inc.88
已完成
不适用
A Phase I/IIa Study Assessing Single and Multiple Doses of study drug in Healthy and Genotype 1 HCV-Infected Subjectsinfectious liverdisease10047438Hepatitis CNL-OMON35061Idenix Pharmaceuticals Inc50