NCT01554085终止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 of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 78
- 试验地点
- 5
- 主要终点
- Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
研究概览
简要总结
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002158 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection.
Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV.
Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject has provided written consent.
- •Subject is in good health as deemed by the investigator
- •Creatinine clearance of greater than 50 mL/min (Cockcroft- Gault).
- •Male or female, 18-55 years of age for HV and 18-65 years of age for subjects with CHC.
- •Body mass index (BMI) 18-32 kg/m2 inclusive for HV and 18-36 kg/m2 for subjects with CHC, minimum weight 50 kg in both populations.
- •A female is eligible to participate in this study if she is of non-childbearing potential.
- •If male, subject is surgically sterile or practicing specific forms of birth control.
- •Additional inclusion criteria for subjects with CHC genotype 1 infection:
- •Positive HCV antibody and a positive HCV RNA at screening.
- •Documentation of CHC infection of greater than 6 months duration at screening.
- •CHC genotype 1 infection at screening.
- •HCV RNA viral load ≥ 105 and ≤ 108 IU/mL using a sensitive quantitative assay
- •Liver biopsy within two years or Fibroscan evaluation within 6 months prior to screening that clearly excludes cirrhosis. Fibroscan liver stiffness score must be < 12 kPa.
- •Absence of hepatocellular carcinoma as indicated by an abdominal ultrasound scan during screening.
- •No prior treatment for CHC.
- •Absence of history of clinical hepatic decompensation.
- •Laboratory values include:
- •prothrombin time < 1.5 × ULN.
- •platelets > 120,000/mm
- •albumin > 3.5 g/dL, bilirubin < 1.5 mg/dL at screening (subjects with documented Gilbert's disease allowed).
- •Serum ALT concentration < 5 × ULN.
- •Alpha Fetoprotein (AFP) concentration ≤ ULN. If AFP is ≥ ULN, absence of a hepatic mass must be demonstrated by ultrasound within the screening period.
排除标准
- •Clinically significant cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder.
- •Positive test for HAV IgM, HBsAg, HCV Ab (HV only), or HIV Ab.
- •Abnormal screening laboratory results that are considered clinically significant by the investigator.
- •Clinically significant drug allergy such as, but not limited to, sulfonamides and penicillins, including those experienced in previous trials with experimental drugs.
- •Participation in an investigational drug trial or having received an investigational vaccine within 30 days or 5 half lives (whichever is longer) prior to receiving study medication.
- •Clinically significant blood loss or elective blood donation of significant volume.
- •Laboratory abnormalities including:
- •Thyroid Stimulating Hormone (TSH) >ULN.
- •Hematocrit < 34 %.
- •White blood cell counts < 3,500/mm
- •For healthy volunteers, history of regular use of tobacco.
- •The subject has a positive pre-study drug screen.
研究组 & 干预措施
ALS-002158
Experimental
干预措施: ALS-002158 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Tabulation of adverse events, physical exam, vital signs, 12-lead ECGs, and clinical lab results
时间窗: Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31
次要结局
- Pharmacokinetic parameters and urinary excretion of ALS-002158 and metabolites(Part 1: Day 1-8; Part 2: Day 1-16; Part 3: Day 1-31)
- HCV ribonucleic acid (RNA) viral load reduction(Baseline to Day 31)
- Sequence analysis of the Hepatitis C virus (HCV) NS5B region(Baseline up to Month 6)
研究者
研究点 (5)
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