NCT03515980已完成1 期
A Phase 1, Open-Label, Parallel Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986231 in Participants With Varying Degrees of Hepatic Impairment
Bristol-Myers Squibb4 个研究点 分布在 2 个国家目标入组 76 人开始时间: 2018年5月25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
- 76
- 试验地点
- 4
- 主要终点
- Area under the concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] derived from plasma concentration
研究概览
简要总结
This is an investigational study of experimental Medication BMS-986231 given to participants with weakened or damaged liver 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 and BMI ≥ 18 kg/m2 and ≤ 35 kg/m2
- •Heart rate ≥ 50 bpm and < 95 bpm
- •Women of childbearing potential must have a negative urine or serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 24 hours prior to the start of study treatment
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 volunteer
- •History of chronic headaches (defined as occurring 15 days or more a month, over the previous 3 months), headaches related to caffeine withdrawal (ie, coffee, soda, tea, energy drinks, etc.), or moderately severe to severe headaches
- •History of migraine or cluster headaches
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Mild hepatic impairment
Experimental
Based on Hepatic Function Impairment - Child-Pugh A score 5 to 6 points
干预措施: BMS-986231 (Drug)
Moderate hepatic impairment
Experimental
Based on Hepatic Function Impairment - Child-Pugh B score 7 to 9 points
干预措施: BMS-986231 (Drug)
Severe hepatic impairment
Experimental
Based on Hepatic Function Impairment - Child-Pugh C score 10 to 15 points
干预措施: BMS-986231 (Drug)
Normal hepatic function
Experimental
Based on Hepatic Function Impairment as defined by the investigator
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(INF)] derived from plasma concentration
时间窗: Up to 2 days
AUC from time 0 up to time T, where T is the last time point with concentrations above the lower limit of quantitation [AUC(0-T)] derived from plasma concentration
时间窗: Up to 2 days
Maximum plasma concentration (Cmax)
时间窗: Up to 2 days
次要结局
- Incidence of adverse events (AE)(Up to 33 days)
- Incidence of serious adverse events (SAE)(Up to 33 days)
- Incidence of Laboratory Test Result Abnormalities(Up to 11 days)
- Clearance (CL) derived from plasma concentration(Up to 2 days)
- Terminal elimination half-life (t1/2) derived from plasma concentration(Up to 2 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 2 days)
- Terminal elimination phase rate constant (λz) derived from plasma concentration(Up to 2 days)
- Volume of distribution during terminal phase (Vz) derived from plasma concentration(Up to 2 days)
- Metabolite ratio determined using AUC(INF) for metabolite/AUC(INF) for BMS-986231 [MRAUC(INF)] derived from plasma concentration(Up to 2 days)
研究者
研究点 (4)
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