NCT03196206已完成1 期
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS- 986177 in Participants With Normal Renal Function and Participants With Moderate and Severe Renal Impairment
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2017年7月13日最近更新:
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
- 24
- 试验地点
- 3
- 主要终点
- AUC from time zero extrapolated to infinite time (AUC (INF))
研究概览
简要总结
Assess the pharmacokinetics, safety, and tolerability of a single dose of BMS-986177 in participants with normal renal function and moderate to severe renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in Groups B and C will be classified by renal function by eGRF at screening and confirmed on Day -1
- •Participants in Group A will be healthy participants as determined by no significant deviations in normal medical and surgical history and assessments
- •Participants in Group A must have a body mass index of 18.0 to 32.0 kg/m2, inclusive
- •Females must be of non-childbearing potential
排除标准
- •Participants in Groups B and C cannot have an indwelling catheter for hemodialysis
- •Participants in Groups B and C cannot have had, nor be waiting for, an organ transplant
- •Other protocol defined inclusion and exclusion criteria could apply
研究组 & 干预措施
Group A
Experimental
Normal Renal Function
干预措施: BMS-986177 (Drug)
Group B
Experimental
Moderate Renal Impairment
干预措施: BMS-986177 (Drug)
Group C
Experimental
Severe Renal Impairment
干预措施: BMS-986177 (Drug)
结局指标
主要结局
AUC from time zero extrapolated to infinite time (AUC (INF))
时间窗: Up to 5 days
Summary measures of PK parameters
AUC from time zero to time of last quantifiable concentration (AUC (0-T))
时间窗: Up to 5 days
Summary measures of PK parameters
Maximum observed plasma concentration (Cmax)
时间窗: Up to 5 days
Measured by plasma concentration
次要结局
- Change from baseline in physical examination findings(Up to 5 days)
- Incidence of Adverse Events (AEs)(Up to 5 days)
- Change from baseline in electrocardiogram findings(Up to 5 days)
- Incidence of Serious Adverse Events ( SAEs)(Up to 30 days)
- Change from baseline in clinical laboratory test findings(Up to 5 days)
研究者
研究点 (3)
Loading locations...
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