EUCTR2009-018079-15-HU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 Subjects
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
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 from first dose through at least 90 days after the last dose of the study drug.
- •4.Subject must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
- •5.Agrees not to consume grapefruit juice within 48 hours of reporting to the clinic on Day -1 through the end of the study.
- •6.Pulse = 40 BPM, systolic blood pressure = 95 mmHg and QTcF interval = 450 ms at screening and Day -1.
- •7.Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
- •8.Subject has provided written informed consent to participate in the study.
- •Part A Specific (must also meet the following)
- •9.Subject must be male.
- •Part C and D Specific (must also meet the following)
- •10.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)
- •11.Male or female subjects may be included. If female, subject must be of non-childbearing potential. Non-childbearing potential is defined as one of the following:
- •Post-menopausal, defined as amenorrheic for at least 2 years and serum FSH level = 27 IU/L at screening.
- •A documented hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to study initiation.
- •12. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
- •anti-HCV antibody positive at least six months prior to screening or dosing OR
- •HCV RNA present in plasma by a sensitive and specific assay at least six months prior to screening or dosing OR
- •Histologic evidence of chronic hepatitis C infection (Note: Subjects with cirrhosis are excluded, see exclusion #19.)
- •13.Plasma HCV RNA = 5 log10 IU/mL at screening.
- •14.HCV genotype 1 by HCV genotyping performed at screening.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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. This includes drugs given for therapeutic reasons.
- •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). A washout period of at least 5 half-lives of the CYP 3A4 drug must be observed prior to study drug dosing, if the investigator feels that the drug can be safely discontinued or substituted for the duration of the study.
- •6.Use of other investigational drugs within 60 days of dosing, or plans to enroll 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 ECG at screening or Day -1.
- •10.Serum creatinine > ULN
- •11.Estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the 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 (see Appendix 3), 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:
- •Primary or secondary causes of liver disease (other than hepatitis C). For example, alcoholism, autoimmune hepatitis, nonalcoholic steatohepatitis, drug-related liver disease, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson’s Disease, Gilbert’s syndrome, Dubin-Johnson syndrome, other congenital or metabolic conditions affecting the liver, etc.
- •Malignant disease or suspicion or history of malig
研究者
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