A Phase 1, Open-Label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of BMS-986224 in Participants 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
- 50
- 试验地点
- 3
- 主要终点
- Renal clearance of BMS-986224 derived from urine concentration
研究概览
简要总结
The purpose of this study is to investigate the experimental medication BMS-986224 in participants with varying levels of renal 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥18 and ≤ 35kg/m2
- •Systolic blood pressure >100 mmHg
排除标准
- •Women of childbearing potential or women who are currently pregnant
- •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
- •Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Normal Renal Function
干预措施: BMS-986224 (Drug)
Mild Renal Impairment
干预措施: BMS-986224 (Drug)
Moderate Renal Impairment
干预措施: BMS-986224 (Drug)
Severe Renal Impairment
干预措施: BMS-986224 (Drug)
End-Stage Renal Disease (ESRD)
ESRD participants and are on chronic hemodialysis
干预措施: BMS-986224 (Drug)
结局指标
主要结局
Renal clearance of BMS-986224 derived from urine concentration
时间窗: 7 days
Part 1 only
Maximum observed plasma concentration (Cmax) of BMS-986224
时间窗: Up to 11 days
Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of BMS-986224
时间窗: Up to 11 days
Fraction of dose excreted in urine (Fe%) of BMS-986224
时间窗: 7 days
Part 1 only
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
时间窗: Up to 11 days
Time of maximum observed plasma concentration (Tmax) of BMS-986224
时间窗: Up to 11 days
Terminal elimination half-life (T-HALF) of BMS-986224 derived from plasma concentration
时间窗: Up to 11 days
Fraction of unbound drug in plasma (fu) of BMS-986224
时间窗: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
时间窗: Up to 11 days
Apparent oral clearance (CL/F) of BMS-986224 derived from plasma concentration
时间窗: Up to 11 days
Apparent volume of distribution (Vz/F) of BMS-986224 derived from plasma concentration
时间窗: Up to 11 days
Cumulative amount of unchanged drug excreted into the urine at a given time (Aet) of BMS-986224
时间窗: 7 days
Part 1 only
次要结局
- Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation(Up to 41 days)
- Maximum observed plasma concentration (Cmax) of metabolite(Up to 11 days)
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of metabolite(Up to 11 days)
- Area under the plasma concentration-time curve from time zero to 72 h post dose [AUC(0-72)] of metabolite(Up to 11 days)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of metabolite(Up to 11 days)
- Time of maximum observed plasma concentration (Tmax) of metabolite(Up to 11 days)
- Terminal elimination half-life (T-HALF) of metabolite derived from plasma concentration(Up to 11 days)
- Metabolite-to-parent (MR) ratio for cMax(Up to 11 days)
- Metabolite-to-parent (MR) ratio for AUC(0-T)(Up to 11 days)
- Metabolite-to-parent (MR) ratio for AUC(0-72)(Up to 11 days)
- Metabolite-to-parent (MR) ratio for AUC(INF)(Up to 11 days)
- Number of clinically significant changes in vital signs, ECGs, physical examinations, or clinical laboratory tests(Up to 11 days)