NCT02108639已完成1 期
An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of DCV, ASV, and BMS-791325 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014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
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 4
- 主要终点
- Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712
研究概览
简要总结
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
详细描述
IND Number: 79,599/101,943
Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses
Fixed dose combination (FDC)
Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects in Group A must be in good health and have normal renal function
- •Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
- •Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods
排除标准
- •Subjects in Group A must not have any significant acute or chronic illnesses
- •Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
- •Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
- •Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration
研究组 & 干预措施
DCV 3DAA FDC + BMS-791325
Experimental
Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
干预措施: DCV 3DAA FDC (Drug)
DCV 3DAA FDC + BMS-791325
Experimental
Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
干预措施: BMS-791325 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712
时间窗: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712
时间窗: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
次要结局
- Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Safety based on abnormalities in vital sign measurements(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Protein Binding for DCV, ASV, BMS-791325 and BMS-794712(1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only))
- Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Maximum observed concentration (Cmax) for BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Safety based on findings on ECG measurements and physical examinations(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
- Safety based on Marked abnormalities in clinical laboratory test findings(For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13)
研究者
研究点 (4)
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