EUCTR2013-004043-23-BE进行中（未招募）1 期
A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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. Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
- •2. Male or female subjects between 18 and 65 years of age, inclusive (or the legal age of consent per local regulations).
- •3. Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2 (Group A) or 18-35 kg/m2 (Groups B-E), inclusive.
- •4. All subjects of childbearing potential must have agreed to use a double-method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
- •Non-childbearing potential is defined as:
- •Females: postmenopausal, defined as amenorrheic for at least 2 years and serum follicle stimulating hormone (FSH) level consistent with postmenopausal status at Screening, or a self-reported hysterectomy, bilateral oophorectomy or bilateral tubal ligation at least 6 months prior to Screening.
- •Males: a self-reported vasectomy at least 6 months prior to Screening.
- •5. Females must have a negative serum beta-human chorionic gonadotropin (ß-HCG) at Screening and a negative pregnancy test (urine or ß-HCG) at Day -1.
- •6. Male subjects must have agreed not to donate sperm from the first dose through 90 days after the last dose of study drug.
- •7. Subject must not have consumed grapefruit or grapefruit juice within 7 days of reporting to the clinic on Day -1, and agrees not to do so through the end of the study.
- •8. Subject is, in the opinion of the investigator, willing and able to comply with the study drug regimen and all other study requirements.
- •Group A Specific (must also meet the following)
- •9. Subject must not have smoked or used nicotine-containing products within 6 months prior to Day -1 and agrees not to do so for the duration of the study.
- •Groups B, C, D and E Specific (must also meet the following)
- •10. Subjects in Group B may have received prior treatment with interferon (IFN) and ribavirin for hepatitis C infection but not treatment with any direct-acting antivirals (DAA). Subjects in Groups C, D and E must be HCV treatment-naïve (i.e., no prior exposure to any antiviral treatment for hepatitis C infection).
- •11. Documented clinical history compatible with chronic hepatitis C, including any one of the following:
- •anti- HCV antibody positive at least 6 months prior to Screening or dosing, OR
- •HCV genotype results at least 6 months prior to Screening or dosing, OR
- •HCV RNA present in plasma by a sensitive and specific assay at least 6 months prior to Screening or dosing, OR
- •Histologic evidence of chronic hepatitis C infection
- •12. HCV Genotype 1, 2, 3, 4, 5 or 6 by HCV genotyping performed at Screening (genotype dependent on the group/cohort enrolling). Note: For a specific genotype, mixed subtypes are acceptable but mixed genotypes are not.
- •13. Plasma HCV RNA = 5.0 log10 IU/mL at Screening.
- •Group E Specific (must also meet the following)
- •14. Subjects must be Child-Pugh Class A.
- •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 132
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Female subject is pregnant or breastfeeding.
- •2. Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV).
- •3. Donated more than 500 mL of blood or had significant blood loss 60 days prior to dosing.
- •4.Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator.
- •5.Positive screen result for drugs of abuse or alcohol at Screening or on Day –1.
- •6.Concomitant use of any known major inhibitor or inducer of cytochrome P450 (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.
- •7.Concomitant use of herbal or dietary supplements. A washout period of at least 7 days must be observed prior to study drug dosing.
- •8.Concomitant use of acid blockers (e.g., proton-pump inhibitors). A washout period of at least 5 half-lives 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. Antacids (stomach acid neutralizers such as calcium carbonate or aluminum hydroxide-based products) will be allowed during the study, except ±4 h of dosing.
- •9.Concomitant use of the following medications: amlodipine, aripiprazole, atorvastatin, carvedilol, diazepam, diltiazem, fluoxetine, isradipine, perphenazine, procainamide, simvastatin, thioridazine or verapamil. A washout period of at least 5 half-lives must be observed prior to initiating study drug dosing, if the investigator feels that the drug can be safely discontinued or substituted for the duration of the study.
- •10.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.
- •11.Subject with intestinal malabsorption (e.g., structural defects, digestive failure or enzyme deficiencies with the exception of lactose intolerance).
- •12.Subject with known allergy to the study medication or any of its components.
- •13.Cardiac disease, family history of congenital heart disease, family history of prolonged QT, or family history of sudden death of unknown etiology.
- •14.One or more of the following abnormalities:
- •First degree, or greater, heart block.
- •QTcF interval = 430 ms for males or = 450 ms for females, at Screening, Day -1 and Day 1 (prior to the first dose).
- •Clinically significant abnormal ECG at Screening or Day -1, as determined by the investigator.
- •15.At Screening or Day -1: an estimated glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 as estimated by the Modification of Diet in Renal Disease (MDRD) formula.
- •16.Hemoglobin (Hgb) < 13.0 g/dL for males, < 12.0 g/dL for females.
- •17.Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •Group A Specific (following also excluded)
- •18.Concomitant use of prescription medications, or systemic over-the-counter 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.
- •19.Abnormal laboratory values at Screening or Day -1 that are considered to be clinically significant by the investigator(s).
- •20.Positive sc
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）
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
已完成
不适用
Evaluation of IDX375 in healthy and hepatitis C-infected subjectsGenotype 1 chronic hepatitis C virusInfections and InfestationsChronic viral hepatitisISRCTN80501908Idenix Pharmaceuticals, Inc. (USA)78