A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Total amount of TRA recovered in feces (FR)
研究概览
简要总结
The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
- •Body mass index between 18.0 to 33.0 kg/m2 (inclusive)
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
- •History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Treatment Group 1: BMS-986166
干预措施: BMS-986166 (Drug)
Treatment Group 1: BMS-986166
干预措施: Bisacodyl (Drug)
结局指标
主要结局
Total amount of TRA recovered in feces (FR)
时间窗: Up to 90 days
Total amount of total radioactivity (TRA) recovered in urine (UR)
时间窗: Up to 90 days
Total amount of TRA recovered in urine and feces combined (RTotal)
时间窗: Up to 90 days
Percent of TRA recovered in feces (%FR)
时间窗: Up to 90 days
Time of maximum observed concentration (Tmax)
时间窗: Up to 89 days
Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
时间窗: Up to 89 days
Percent of TRA recovered in urine (%UR)
时间窗: Up to 90 days
Percent of TRA recovered in urine and feces combined (%TOTAL)
时间窗: Up to 90 days
Maximum observed concentration (Cmax)
时间窗: Up to 89 days
次要结局
- Maximum observed concentration (Cmax)(Up to 89 days)
- Number of participants with clinical laboratory test abnormalities(Up to 90 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 90 days)
- Number of participants with adverse events (AEs)(Up to 124 days)
- Number of participants with serious adverse events (SAEs)(Up to 124 days)
- Number of participants with vital sign abnormalities(Up to 90 days)
- Number of participants with physical examination abnormalities(Up to 90 days)
- Time of maximum observed concentration (Tmax)(Up to 89 days)
- Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)](Up to 89 days)