NCT01525212撤回1 期
Double-Blinded, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of BMS-929075 in Treatment Naive Subjects Infected With Hepatitis C Virus Genotype 1
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2012年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- HCV RNA level on Day 4
研究概览
简要总结
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Men and women, ages 18 to 65 years, inclusive
- •Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy
- •HCV genotype 1a or 1b only
- •HCV RNA viral load of ≥ 100,000 IU/mL
- •Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day 1 showing absence of cirrhosis
- •Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive
排除标准
- •Any significant acute or chronic medical illness
- •History of adrenal gland disease, including but not limited to adrenal insufficiency or Cushing's syndrome
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery that could impact upon the absorption of study drug
- •Positive for hepatitis B surface antigen (HBsAg)
- •Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies
- •Smoking > 10 cigarettes per day
- •Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5x upper limit of normal (ULN)
- •Total Bilirubin ≥ 1.5x ULN
- •Hemoglobin < 10 g/dL
- •Platelets < 75,000 cell/μL
- •ALC (absolute lymphocyte count) < 1000 cell/μL
- •Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60 mL/min
研究组 & 干预措施
Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075
Experimental
干预措施: BMS-929075 (Drug)
Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075
Experimental
干预措施: BMS-929075 (Drug)
Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075
Experimental
干预措施: Placebo matching BMS-929075 (Drug)
Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075
Experimental
干预措施: BMS-929075 (Drug)
Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075
Experimental
干预措施: Placebo matching BMS-929075 (Drug)
Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075
Experimental
干预措施: Placebo matching BMS-929075 (Drug)
Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075
Experimental
干预措施: BMS-929075 (Drug)
Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075
Experimental
干预措施: Placebo matching BMS-929075 (Drug)
结局指标
主要结局
HCV RNA level on Day 4
时间窗: Within 4 days after the first dose
次要结局
- Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28(Days 1-28)
- Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28(Days 1-28)
- Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests(Days 1-28 (with SAE from screening to Day 30))
- Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- Protein Binding (PB) of BMS-929075 derived from plasma concentration versus time(Day 3 (0h and 2h))
- Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus time(Day 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h))
- The relationship between antiviral activity and measures of exposure to BMS-929075(Days 1-6)
研究者
研究点 (1)
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