An Open-label Study to Evaluate the Pharmacokinetics and Safety of BMS-663068 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-Stage Renal Dysfunction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effect of Renal Impairment on The Primary Endpoints of Cmax
研究概览
简要总结
An oral dose in healthy and renally impaired subjects to determine the drug effect for BMS-663068.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening
- •Evidence of rapidly deteriorating renal function, defined as a screening eGFR that has decreased from a previous eGFR by ≥ 50% within the last 3 months
- •Current or recent (within 3 months of study drug administration) clinically significant gastrointestinal disease or gastrointestinal surgery (including cholecystectomy) that could impact the absorption of study drug
- •Any major surgery within 4 weeks of study drug administration.
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Healthy Subjects
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
干预措施: Oral BMS-663068 (pro-drug) (Drug)
Mild Renal Impairment Subjects
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
干预措施: Oral BMS-663068 (pro-drug) (Drug)
Moderate Renal Impairment Subjects
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
干预措施: Oral BMS-663068 (pro-drug) (Drug)
Severe Renal Impairment Subjects
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
干预措施: Oral BMS-663068 (pro-drug) (Drug)
End Stage Renal Disease Subjects
A single dose of pro-drug, BMS-663068, administered orally and then metabolized to active BMS-626529 on Day 1.
干预措施: Oral BMS-663068 (pro-drug) (Drug)
结局指标
主要结局
Effect of Renal Impairment on The Primary Endpoints of Cmax
时间窗: Day 1 - Day 5
To assess the effect of varying degrees of renal impairment on the exposure of BMS-626529 after a single oral-dose administration of the pro-drug, BMS-663068, will be evaluated by assessing the primary endpoints of Cmax, for BMS-626529.
次要结局
- Safety and Tolerability as assessed by the Incidence of Serious Adverse Events (SAEs), Adverse Events (AEs), AEs leading to discontinuation, and the results of ECGs, vital signs, physical examination, and clinical laboratory tests.(Day 1 - Day 5)