NCT06723535已完成1 期
An Open-Label, Single-Dose, Phase 1 Study to Evaluate the Pharmacokinetics and Safety of BMS-986278 in Participants With Normal Renal Function, Participants With Severe Renal Impairment, and Participants With End-Stage Renal Disease on Intermittent Hemodialysis
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2024年12月7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
- 27
- 试验地点
- 4
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18 and 45 kg/m2 inclusive, and body weight ≥ 50 kg at screening. Note: for ESRD participants, this body weight should be the prescription dry weight.
- •Severe Renal Impaired Participants:
- •Participant has a supine SBP ≥ 90 and ≤ 180 mmHg, supine DBP ≥ 60 and ≤ 100 mmHg, and heart rate ≥ 40 and ≤ 110 beats per minute.
- •Participant has severe RI as defined by an eGFR ˂ 30 mL/min and not requiring dialysis at screening.
- •Participant must be medically stable for at least 1 month before study intervention administration.
- •Participants with ESRD:
- •Participant has ESRD as defined by an eGFR < 15 mL/min at screening.
- •Participant required to be on intermittent hemodialysis, an average of 3 hemodialysis treatments per week prior to screening.
- •Participant has demonstrated adequate hemodialysis measurements (at least 2 Kt/V measurements ≥ 1.2 or 2 urea reduction ratio measurements ≥ 65%) within the 3 months prior to screening.
- •Healthy participant should have a supine SBP ≥ 90 and ≤ 160 mm Hg, supine DBP ≥ 50 and ≤ 100 mm Hg, and heart rate ≥ 40 and ≤ 100 beats per minute.
- •Healthy participants should have normal renal function, as defined by having an eGFR ≥ 90 mL/min eGFR at screening (calculated using the CKD-EPI equation).
排除标准
- •Participant with any significant medical condition, laboratory abnormality, or psychiatric illness.
- •Any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, or excretion (eg, bariatric procedure or cholecystectomy).
- •Individuals who are of childbearing potential, breastfeeding, or currently pregnant.
- •Other protocol defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Group A and C
Experimental
干预措施: BMS-986278 (Drug)
Group B: Period 1
Experimental
干预措施: BMS-986278 (Drug)
Group B: Period 2
Experimental
干预措施: BMS-986278 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
时间窗: Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Up to Day 8
次要结局
- Number of participants with physical examination abnormalities(Up to Day 8)
- Number of participants with vital sign abnormalities(Up to Day 8)
- Number of participants with adverse events (AEs)(Up to 28 days following discontinuation of dosing)
- Number of participants with 12-lead electrocardiogram (ECG) abnormalities(Up to Day 8)
- Number of participants with clinical laboratory abnormalities(Up to Day 8)
- Time of maximum observed concentration (Tmax)(Up to Day 8)
- Terminal elimination half-life (T-HALF)(Up to Day 8)
- Apparent body clearance (CLT/F)(Up to Day 8)
- Apparent volume of distribution of terminal phase (Vz/F)(Up to Day 8)
- Concentration of BMS-986278 in dialysate(Up to Day 8)
- Total amount recovered in dialysate (DR)(Up to Day 8)
- Total percent of administered dose recovered in dialysate (%DR)(Up to Day 8)
- Free fraction of unbound drug (Fu)(Up to Day 8)
- Unbound Cmax (Cmax_u)(Up to Day 8)
- Unbound AUC(0-T) (AUC(0-T) _u)(Up to Day 8)
- Unbound AUC(INF) (AUC(INF)_u)(Up to Day 8)
- Unbound CLT/F (CLT/F_u)(Up to Day 8)
- Unbound Vz/F (Vz/F_u)(Up to Day 8)
研究者
研究点 (4)
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