A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Subjects With Varying Degrees of Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
研究概览
简要总结
The purpose of this study is to investigate experimental medication BMS-986231 in patients 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
- •Body weight ≥ 45 kg and ≤ 120 kg
- •BMI ≥ 18 kg/m^2 and ≤ 35 kg/m^2
- •Heart rate ≥ 50 bpm and < 95 bpm
- •Stable renal impairment, defined as no clinically significant change in disease status, as documented by the subject's most recent eGFR assessment
- •No changes in medication within 30 days prior to study drug administration
排除标准
- •Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests
- •History of chronic headaches, defined as occurring 15 days or more a month, over the previous 3 months
- •History of headaches related to caffeine withdrawal
- •History of migraine or cluster headaches
- •Patients requiring dialysis will not be enrolled in this study
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Mild Renal Impairment
Mild renal impairment defined as eGFR 60 to <90 mL/min/1.73 m^2
干预措施: BMS-986231 (Drug)
Moderate renal impairment
Moderate renal impairment defined as eGFR 30 to <60 mL/min/1.73 m^2
干预措施: BMS-986231 (Drug)
Severe renal impairment
Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2, not requiring dialysis
干预措施: BMS-986231 (Drug)
Normal renal function
Normal renal function defined as eGFR ≥90 mL/min/1.73 m^2
干预措施: BMS-986231 (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(0-inf)] derived from plasma concentration
时间窗: 11 days
Metabolite ratio determined using AUC0-inf for metabolite/AUC0-inf [MRAUC(0-inf)] derived from plasma concentration
时间窗: 11 days
Renal clearance (CLR) derived from urine concentration
时间窗: 11 days
Maximum observed plasma concentration (Cmax) derived from plasma concentration
时间窗: 11 days
Clearance (CL) derived from plasma concentration
时间窗: 11 days
次要结局
- Number of serious adverse events (SAE)(Up to 31 days)
- Terminal elimination phase rate constant (λz)(Up to 36 hours)
- Number of adverse events (AE)(Up to 31 days)
- Terminal elimination half-life (t1/2)(Up to 36 hours)
- Volume of distribution during terminal phase (Vz)(Up to 36 hours)
- Fraction of administered drug excreted into urine (Fe)(Up to 36 hours)
- Time of maximum observed plasma concentration (Tmax)(Up to 36 hours)
- Cumulative amount excreted from time 0 to the time of the last quantifiable sample (Aelast)(Up to 36 hours)
- AUC up to time t, where t is the last time point with concentrations above the lower limit of quantitation (AUCt)(Up to 36 hours)