To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
2014年7月9日 更新者:Bristol-Myers Squibb
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
Assess the effect of renal function on the blood levels of DCV, ASV, BMS-791325.
研究概览
详细说明
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)
研究类型
介入性
注册 (实际的)
41
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Florida
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Miami、Florida、美国、33014
- Clinical Pharmacology Of Miami Inc.
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Orlando、Florida、美国、32809
- Orlando Clinical Research Center
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Minnesota
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Minneapolis、Minnesota、美国、55404
- Davita Clinical Research
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Tennessee
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Knoxville、Tennessee、美国、37920
- New Orleans Center For Clinical Research - Knoxville
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:DCV 3DAA FDC + BMS-791325
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 |
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712
大体时间:For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
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For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
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Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712
大体时间:For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
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For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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BMS-948158 may also be analyzed
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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BMS-948158 may also be analyzed
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Protein Binding for DCV, ASV, BMS-791325 and BMS-794712
大体时间:1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)
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1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)
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Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Maximum observed concentration (Cmax) for BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Safety based on abnormalities in vital sign measurements
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Safety based on findings on ECG measurements and physical examinations
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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Safety based on Marked abnormalities in clinical laboratory test findings
大体时间:For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2014年4月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2014年4月7日
首先提交符合 QC 标准的
2014年4月7日
首次发布 (估计)
2014年4月9日
研究记录更新
最后更新发布 (估计)
2014年7月10日
上次提交的符合 QC 标准的更新
2014年7月9日
最后验证
2014年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Haisco Pharmaceutical Group Co., Ltd.完全的
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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Bristol-Myers Squibb完全的
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Bristol-Myers Squibb完全的
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Bristol-Myers Squibb完全的丙型肝炎病毒大韩民国, 台湾, 俄罗斯联邦
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Bristol-Myers Squibb完全的
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