Effect of Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Therapy on the Pharmacokinetics of Rosuvastatin
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 主要终点
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin
研究概览
简要总结
The primary purpose is to assess the effect of Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 combination therapy on the exposure of Rosuvastatin.
详细描述
IND Number: 79,599/101,943
Primary Purpose: Other - Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects with no clinically significant deviations from normal in medical history, physical exam findings, 12 lead ECG measurements and clinical laboratory tests
- •Females must be of non-childbearing potential
排除标准
- •Women of childbearing potential
- •Any significant acute or chronic medical condition
- •Inability to tolerate oral medications
- •Inability to be venipunctured and/or tolerate venous access
- •Abnormal liver function tests
- •Current or recent (within 3 months of dosing) gastrointestinal disease
研究组 & 干预措施
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
Treatment A: Rosuvastatin tablet orally on specified days
Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days
Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days
干预措施: Daclatasvir, Asunaprevir and BMS-791325 FDC (Drug)
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
Treatment A: Rosuvastatin tablet orally on specified days
Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days
Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days
干预措施: BMS-791325 (Drug)
Arm 1: DCV/ASV/BMS-791325 FDC + BMS-791325 + Rosuvastatin
Treatment A: Rosuvastatin tablet orally on specified days
Treatment B: Daclatasvir, Asunaprevir and BMS-791325 Fixed dose combination (FDC) + BMS-791325 tablet orally on specified days
Treatment C: Daclatasvir, Asunaprevir and BMS-791325 FDC + BMS-791325 + Rosuvastatin tablet orally on specified days
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of Rosuvastatin
时间窗: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Maximum observed concentration (Cmax) of Rosuvastatin
时间窗: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin
时间窗: Day 1 (predose) to Day 5 (96 hours) and Day 15 (predose) to Day 19 (96 hours)
次要结局
- Half life (T-HALF) of Rosuvastatin(Days 1 and 15 (predose through 96 hours))
- Maximum observed concentration (Cmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712(Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose)
- Trough observed plasma concentration (predose) (Ctrough) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712(Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose)
- Safety measured by incidence of Adverse events (AEs), Serious adverse events (SAEs) and AEs leading to discontinuation(Days 1 through 19)
- Apparent total body clearance (CLT/F) of Rosuvastatin(Days 1 and 15 (predose through 96 hours))
- Time of maximum observed concentration (Tmax) of Rosuvastatin(Days 1 and 15 (predose through 96 hours))
- Area under the concentration-time curve in one dosing interval [AUC(TAU)] of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712(Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose)
- Time of maximum observed concentration (Tmax) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712(Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose)
- Observed plasma concentration at 12 hours after dosing in a pharmacokinetic (PK) profile (C12) of Daclatasvir, Asunaprevir and BMS-791325 and BMS-794712(Day 15 (predose through 12 hours) and Days 13 and 14 pre-AM-dose)
- Safety measured by results of vital sign measurements, Electrocardiogram (ECGs), physical examinations and clinical laboratory tests(Days 1 through 19)