An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
研究概览
简要总结
The purpose of this study is to assess the effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.
详细描述
IND Number: 100,932/79,599/101,943
Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects ages 18 to 49 years, inclusive.
- •Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
- •History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
- •Use of tobacco-containing or nicotine-containing products
- •Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
- •PR ≥210 msec
- •QRS ≥120 msec
- •QT ≥500 msec
- •QTcF ≥450 msec
- •Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
- •Alanine aminotransferase (ALT) >Upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) >ULN
- •Total bilirubin (TBILI) >ULN
- •Creatinine >ULN
研究组 & 干预措施
Treatment A: DCV 3DAA FDC fasted state
DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state
干预措施: DCV 3DAA FDC (Drug)
Treatment B: DCV 3DAA FDC with high-fat meal
DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal
干预措施: DCV 3DAA FDC (Drug)
Treatment C: DCV 3DAA FDC with light meal
DCV 3DAA FDC tablet by mouth once on specified days with light meal
干预措施: DCV 3DAA FDC (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325
时间窗: Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325
时间窗: Day 1 to Day 13
次要结局
- AUC(INF) for BMS-794712(Day 1 to Day 13)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325(Day 1 to Day 13)
- AUC(0-T) for BMS-794712(Day 1 to Day 13)
- T-HALF for BMS-794712(Day 1 to Day 13)
- Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation(Day 1 to Day 13)
- Safety measured by marked abnormalities in clinical laboratory test results(Day 1 to Day 13)
- Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325(Day 1 to Day 13)
- Safety measured by abnormalities in vital sign measurements(Day 1 to Day 13)
- Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations(Day 1 to Day 13)
- Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325(Day 1 to Day 13)
- Cmax for BMS-794712(Day 1 to Day 13)
- Tmax for BMS-794712(Day 1 to Day 13)