NCT03890770已完成1 期
An Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of BMS-986165 in Participants With Normal Renal Function and Participants With Mild, Moderate, and Severe Renal Impairment and in Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
Bristol-Myers Squibb6 个研究点 分布在 4 个国家目标入组 44 人开始时间: 2019年4月4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
- 44
- 试验地点
- 6
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration)
- •Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months
- •Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening
排除标准
- •Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
- •Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit
- •History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Severe renal failure
Experimental
Single dose
干预措施: BMS-986165 (Drug)
End-stage renal disease requiring dialysis
Experimental
Two single doses administered with washout
干预措施: BMS-986165 (Drug)
Normal renal function
Experimental
Single dose
干预措施: BMS-986165 (Drug)
Mild renal disease
Experimental
Single dose
干预措施: BMS-986165 (Drug)
Moderate renal failure
Experimental
Single dose
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Approximately 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
时间窗: Approximately 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Approximately 9 days
次要结局
- Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation(Approximately 45 days)
- Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations(Approximately 45 days)
研究者
研究点 (6)
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