A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986036 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
- 40
- 试验地点
- 4
- 主要终点
- Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
研究概览
简要总结
This is an investigational study to evaluate the experimental medication BMS-986036 in participants 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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI ≥ 25 and ≤ 40 kg/m2
排除标准
- •Presence of any factors that would predispose the participant to infection (eg, extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
- •Any bone trauma (fracture) or bone surgery (ie, hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
- •Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •Any major surgery (eg, abdominal, thoracal, or cranial procedures) within 6 weeks of study drug administration
- •Donation of blood or plasma to a blood bank, or in a clinical study (except at the screening visit) within 6 weeks of study drug administration
- •Inability to tolerate subcutaneous injections
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Mild Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
干预措施: BMS-986036 (Drug)
Moderate Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
干预措施: BMS-986036 (Drug)
Severe Renal Impairment
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
干预措施: BMS-986036 (Drug)
Normal
The renal function will be defined by estimated glomerular filtration rate (eGFR) at Screening.
干预措施: BMS-986036 (Drug)
结局指标
主要结局
Terminal elimination half-life (T-half) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Maximum observed serum concentration (Cmax) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Amount per fraction excreted into urine (Fe) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Time of maximum observed serum concentration (Tmax) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of C-terminal intact BMS-986036
时间窗: Up to 30 days
Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036
时间窗: Up to 30 days
Apparent total body clearance (CLT/F) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Apparent volume of distribution (Vz/F) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Total renal clearance (CLR) of C-terminal intact BMS-986036
时间窗: Up to 30 days
Total amount excreted into urine (Ae) of C-terminal intact BMS-986036
时间窗: Up to 30 days
次要结局
- Incidence of serious adverse events (SAE)(Up to 30 days)
- Incidence of adverse events (AE)(Up to 30 days)
- Maximum observed serum concentration (Cmax) of total BMS-986036(Up to 30 days)
- Time of maximum observed serum concentration (Tmax) of total BMS-986036(Up to 30 days)
- Apparent total body clearance (CLT/F) of total BMS-986036(Up to 30 days)
- Amount per fraction excreted into urine (Fe) of total BMS-986036(Up to 30 days)
- Total amount excreted into urine (Ae) of total BMS-986036(Up to 30 days)
- Incidence of injection site reactions (prospective)(Up to 30 days)
- Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of total BMS-986036(Up to 30 days)
- Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of total BMS-986036(Up to 30 days)
- Terminal elimination half-life (T-half) of total BMS-986036(Up to 30 days)
- Apparent volume of distribution (Vz/F) of total BMS-986036(Up to 30 days)
- Total renal clearance (CLR) of total BMS-986036(Up to 30 days)
- Incidence of clinically significant changes to events of special interest(Up to 30 days)