ACTRN12612000176864招募中1 期
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002158 to Evaluate the Safety, Tolerability and Pharmacokinetics ofSingle Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects with Chronic Hepatitis C Genotype 1 Infection.
CPR Pharma Services0 个研究点目标入组 78 人开始时间: 2012年2月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Subjects must meet all of the following criteria to be included in the study:
- •1. Subject has provided written consent.
- •2. In the investigator’s opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol.
- •3. Subject is in good health as deemed by the investigator, based on the findings of a medical evaluation including medical history, physical examination, laboratory tests,
- •4. Creatinine Clearance of greater than 50 mL/min (Cockroft-Gault)
- •5. Male or female, 18–55 years of age for Healthy Volunteers and 18-65 for subjects with CHC.
- •6. Body mass index (BMI) 18–32 kg/m2 inclusive, minimum weight 50 kg for Healthy Volunteers and 18-36 kg/m2 for subjects with CHC, minimum weight of 50 kg in both populations.
- •No more than 25% of patients in any cohort may be enrolled with Body mass Index of equal or greater than 30 kg/m2.
- •7. A female is eligible to participate in this study if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, bilateral
- •oophorectomy or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and follicle stimulating hormone (FSH) level within the laboratory’s reference range for postmenopausal females
- •8. If male, subject is surgically sterile or practicing specific forms of birth control) until 30 days after the end of the study.
- •In addition, CHC subjects enrolled into the MAD Part (Cohort 1,2 and 3) must also meet the following:
- •1. Positive HCV antibody and a positive HCV RNA at screening.
- •2. Documentation of CHC infection of greater than 6 months duration at screening.
- •3. CHC genotype 1 infection at screening.
- •4. HCV RNA viral load greater than 10to the power of 5 and less than or equal to 10 to the power of 8 IU/mL using a sensitive quantitative assay, e.g., COBAS Taqman- 'Registered Trademark- HCV Test (version 2.0, Roche).
- •5. Liver biopsy within two years or Fibroscan evaluation within 6 months prior to screening that clearly excludes cirrhosis (Knodell score <3, Metavir score <3, Ishak score <4). Fibroscan liver stiffness score must be <12 kPa.
- •6. Absence of hepatocellular carcinoma as indicated by an ultrasound scan conducted during screening.
- •7. No prior treatment for CHC.
- •8. Absence of history of clinical hepatic decompensation, e.g., variceal bleeding, ascites, hepatic encephalopathy, or active jaundice.
- •9. Laboratory values including:
- •prothombin time <1.5 × ULN
- •platelets >120,000/mm3
- •albumin >3.5 g/dL, bilirubin <1.5 mg/dL at screening (subjects with documented Gilbert’s disease allowed)
- •Serum ALT concentration <5 x Upper Limit of Normal
- •Alpha Fetoprotein concentration = ULN. If AFP is = ULN, absence of a hepatic mass must be demonstrated by ultrasound within the screening period.
排除标准
- •Subjects will be ineligible for this study if they meet any one of the following criteria:
- •1. Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
- •2. Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.
- •3. Abnormal screening laboratory results that are considered clinically significant by the investigator.
- •Liver function tests must all be within normal ranges for healthy volunteers (subjects with documented Gilbert’s disease allowed).
- •4. Drug allergy such as, but not limited to, sulfonamides and penicillins, including those experienced in previous trials with experimental drugs.
- •5. Any condition that, in the opinion of the investigator, would compromise the study or the well-being of the subject or prevent the subject from meeting the study
- •requirements.
- •6. Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half-lives (whichever is longer) prior receiving to study medication.
- •7. Clinically significant blood loss or elective blood donation of significant volume (i.e. >500 mL) within 60 days of first dose of study drug; >1 unit of plasma within 7 days of
- •first dose of study drug.
- •8. Clinically significant abnormal electrocardiogram (ECG) findings.
- •9. Pregnant or breast feeding females.
- •10. Unwilling to abstain from alcohol for 48 hours prior to the start of dosing until collection of the final PK sample during each dosing period.
- •11. For healthy volunteers, history regular consumption of >7 units of alcohol for females and >14 units per week for males (one unit is defined as 10 g alcohol) within 6 months
- •of first dose.
- •12. For healthy volunteers, history of regular use of tobacco-(i.e. greater than or equal to 20 cigarettes per day) or nicotine-containing products within 3 months of the screening visit. For subjects with CHC genotype 1 infection, history of regular use of tobacco- or nicotine-containing products is allowed.
- •13. The subject has a positive pre-study drug screen. A minimum list of drugs that will be screened for includes amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.
- •14. Use of concomitant medications, including vitamins or herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study
- •medication, unless in the opinion of the Investigator and Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- •15. Subjects must not have received any medication known to be an inducer or inhibitor of CYP450 enzymes within 3 weeks prior to clinic check-in. Such medications will continue
- •to be prohibited until clinic discharge or commencement of CHC treatment.
- •16. Exposure to more than four new investigational entities within 12 months prior to the first dosing day.
- •17. Laboratory abnormalities including:
- •Thyroid Stimulating Hormone (TSH) >ULN
- •Hematocrit <34 %
- •White blood cell counts < 3,500/mm3
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