ISRCTN44746369已完成不适用
A Phase I/IIa Study Assessing Single and Multiple Doses of Hepatitis C Virus (HCV) Protease Inhibitor IDX320 in Healthy and Genotype 1 HCV-Infected Subjects
Idenix Pharmaceuticals (USA)0 个研究点目标入组 88 人开始时间: 2010年3月25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
- 88
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
- •1. 18-65 years of age, inclusive (or the legal age of consent per local regulations)
- •2. Body Mass Index (BMI) 18-35 kg/m2
- •3. Male subjects must have agreed to use a consistent form of an acceptable double-barrier method of birth control
- •4. Pulse = 40 beats per minute (BPM), systolic blood pressure = 95 mmHg and QTcF interval = 450 ms at screening and Day -1
- •5. Subject has provided written informed consent to participate in the study
- •Part A Specific (must also meet the following)
- •6. Subject must be male.
- •Part C and D Specific (must also meet the following)
- •7. HCV treatment-naïve ? subject must have not received prior antiviral treatment for hepatitis C infection
- •Parts B, C and D Specific (must also meet the following)
- •8. Male or female subjects may be included. If female, subject must be of non-childbearing potential.
- •9. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
- •9.1. anti-HCV antibody positive at least six months prior to screening or dosing OR
- •9.2. HCV ribonucleic acid (RNA) present in plasma by a sensitive and specific assay at least six months prior to screening or dosing OR
- •9.3. Histologic evidence of chronic hepatitis C infection (Note: Subjects with cirrhosis are excluded)
- •10. Plasma HCV RNA = 5 log10 IU/mL at screening
- •11. HCV genotype 1 by HCV genotyping performed at screening
排除标准
- •Initial information at time of registration:
- •1. Co-infected with hepatitis B virus (HBV, HBsAg positive) 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. Positive screen result for drugs of abuse (except THC) or alcohol on Day ?1
- •5. Concomitant use of any known major inhibitor or inducer of cytochrome P450 3A4 (CYP 3A4)
- •6. 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
- •7. Subject with intestinal malabsorption (e.g., structural defects, digestive failure or enzyme deficiencies with the exception of lactose intolerance)
- •8. Subject with known allergy to the study medication or any of its components
- •9. Clinically significant abnormal electrocardiogram (ECG) at screening or Day -1
- •10. Serum creatinine > Upper Limit of Normal (ULN)
- •11. Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) formula
- •PART A Specific (following also excluded)
- •12. History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to admission to the Clinical Unit OR history of smoking within 24 hours prior to admission to the Clinical Unit
- •13. Any clinically significant medical condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •14. 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.
- •15. Abnormal laboratory values at screening or Day -1 that are considered to be clinically significant by the Principal Investigator(s)
- •16. Positive screen for anti-HCV antibody
- •PART B Specific (following also excluded)
- •17. Subject received pegylated interferon and ribavirin within 6 months of screening
- •PART B, C and D Specific (following also excluded)
- •18. Subject is pregnant or breastfeeding. Women must have a negative serum beta-human chorionic gonadotropin (ß-HCG) at screening and Day -1.
- •19. 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
- •20. Prior clinical or histological evidence of cirrhosis (e.g. Metavir 4 or Ishak 6)
- •21. History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
- •22. Active clinically significant diseases including:
- •22.1. Primary or secondary causes of liver disease (other than hepatitis C)
- •22.2. Malignant disease or suspicion or history of malignant disease within previous 5 years (except for adequately treated basal cell carcinoma)
- •22.3. Diabetes mellitus requiring treatment with medication
- •22.4. Any other condition that, in the opinion of the Principal Investigator, would jeopardize the safety of the subject or impact the validity of the study results
- •23. Previously received any other experimental direct-acting antiviral agents targeting the hepatitis C virus (e.g. HCV polymerase or protease inhibitors).
研究者
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