A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
研究概览
简要总结
The purpose of this study is to evaluate the excretion pathway of orally administered [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
- •Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and total body weight ≥ 50 kg
排除标准
- •Any significant acute or chronic medical illness as determined by the investigator.
- •A history of clinically significant hepatic or pancreatic disease.
- •Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
[14C]-BMS-986196
干预措施: [14C]-BMS-986196 (Drug)
结局指标
主要结局
TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
时间窗: Up to Day 15
TRA: 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 15
TRA: Time of Cmax (Tmax)
时间窗: Up to Day 15
TRA: Percent of administered dose recovered in feces (%FR)
时间窗: Up to Day 15
Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 15
TRA: Amount of radioactivity recovered in urine (UR)
时间窗: Up to Day 15
TRA: Amount of radioactivity recovered in feces (FR)
时间窗: Up to Day 15
TRA: Percent of administered dose recovered in urine (%UR)
时间窗: Up to Day 15
TRA: Amount of radioactivity recovered in bile (BR)
时间窗: Up to 14 hours post dose
次要结局
- AUC (0-T)(Up to Day 15)
- Number of Participants with Physical Examination Abnormalities(Up to Day 15)
- Number of Participants with Clinical Laboratory Abnormalities(Up to Day 15)
- Tmax(Up to Day 15)
- Number of Participants with Adverse Events (AEs)(Up to Day 29)
- Number of Participants with Serious AEs (SAEs)(Up to Day 29)
- Number of Participants with AEs Leading to Discontinuation(Up to Day 29)
- Cmax(Up to Day 15)
- Number of Participants with Vital Sign Abnormalities(Up to Day 15)
- Number of Participants with Electrocardiogram (ECG) Abnormalities(Up to Day 15)