A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult 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
- Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
研究概览
简要总结
The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult 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
- •Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
- •Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
- •Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.
排除标准
- •Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
- •Participant must not be currently employed in a job requiring radiation exposure monitoring.
- •Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug
研究组 & 干预措施
Administration of BMS-986322
干预措施: BMS-986322 (Drug)
结局指标
主要结局
Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
时间窗: Up to day 17
Maximum observed in plasma/whole blood concentration (Cmax)
时间窗: Up to day 17
Time of maximum observed in plasma/whole blood concentration (T-max)
时间窗: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to day 17
Apparent total body clearance (CL/F)
时间窗: Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)
时间窗: Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)
时间窗: Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)
时间窗: Up to day 17
Terminal elimination half-life (T-HALF)
时间窗: Up to day 17
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
时间窗: Up to day 17
Total amount of radioactivity recovered in urine (UR)
时间窗: Up to day 17
Total amount of radioactivity recovered in feces (FR)
时间窗: Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)
时间窗: Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to day 17
Total amount of radioactivity recovered in urine and feces combined (RTotal)
时间窗: Up to day 17
次要结局
- Number of participants with serious adverse events (SAEs)(Up to day 47)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to day 17)
- Number of participants with clinical laboratory abnormalities(Up to day 17)
- Number of participants with vital sign abnormalities(Up to day 17)
- Number of participants with clinically significant physical examination findings(Up to day 17)
- Number of participants with adverse events (AEs)(Up to day 47)
- Number of participants with AEs leading to discontinuation(Up to day 47)