NCT01590407已完成1 期
A Randomized, Double-blind, Placebo-controlled, First-in-human, 3-Part Study of Orally Administered ALS-002200 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
- 已完成
- 入组人数
- 71
- 试验地点
- 2
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
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-002200 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.
- •In the investigator's opinion, the subject is able to understand and comply with protocol requirements, instructions, and protocol stated restrictions and is likely to complete the study as planned.
- •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 for greater than 6 months 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 ultrasound scan conducted during screening
- •No prior treatment for CHC
- •Absence of history of clinical hepatic decompensation.
- •Laboratory values include:
- •Prothrombin time < 1.5x 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 alanine aminotransferase (ALT) concentration < 5 x ULN
- •Alpha Fetoprotein (AFP) concentrations ≤ 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.
- •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 study medication.
- •Clinically significant blood loss or elective blood donation of significant volume.
- •For healthy subjects, history of regular use of tobacco.
- •The subject has a positive pre-study drug screen.
- •Laboratory abnormalities including:
- •Thyroid Stimulating Hormone (TSH) > ULN
- •Hematocrit < 34 %
- •White blood cell counts < 3,500/mm3
研究组 & 干预措施
ALS-002200
Experimental
干预措施: ALS-002200 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: up to Day 31
data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results
次要结局
- AUC(pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose)
- HCV ribonucleic acid (RNA) viral load reduction(Baseline to Day 31)
- Cmax(pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose)
- Amino Acid Changes in HCV polymerase NS5b(Baseline up to Month 6)
研究者
研究点 (2)
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