A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C]CC-99677 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
- Total radioactivity recovered in feces (FR)
研究概览
简要总结
The purpose of the study is to characterize the absorption, distribution, metabolism and excretion (ADME) of a single oral dose of [14C] CC-99677.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Body mass index of 18.0 to 33.0 kg/m^2, inclusive
排除标准
- •Any significant acute or chronic medical illness
- •Any major surgery within 4 weeks of intervention administration
- •History of any significant drug allergy
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
CC-99677
干预措施: CC-99677 (Drug)
结局指标
主要结局
Total radioactivity recovered in feces (FR)
时间窗: Up to 15 days
Maximum plasma concentration of the drug (Cmax) for CC-99677
时间窗: Up to 15 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) for CC-99677
时间窗: Up to 15 days
Percent of total radioactivity recovered in urine (%UR)
时间窗: Up to 15 days
Percent of total radioactivity recovered in feces (%FR)
时间窗: Up to 15 days
Percent of total radioactivity recovered in all excreta (%Total)
时间窗: Up to 15 days
Plasma AUC (total radioactivity (TRA))/Blood AUC (TRA)
时间窗: Up to 15 days
Total radioactivity recovered in urine (UR)
时间窗: Up to 15 days
Total radioactivity recovered in bile (BR)
时间窗: Up to 15 days
Time of maximum observed plasma concentration (Tmax) for CC-99677
时间窗: Up to 15 days
Total radioactivity recovered in urine, feces, and bile combined (Rtotal)
时间窗: Up to 15 days
次要结局
- Incidence of serious adverse events (SAEs)(Up to 50 days)
- Incidence of clinical laboratory test abnormalities(Up to 15 days)
- Incidence of adverse events (AEs)(Up to 50 days)
- Incidence of physical examination abnormalities(Up to 15 days)
- AUC(0-T)(Up to 15 days)
- Incidence of AEs leading to discontinuation(Up to 15 days)
- Cmax(Up to 15 days)
- Incidence of vital sign abnormalities(Up to 15 days)
- Incidence of electrocardiogram (ECG) abnormalities(Up to 15 days)
- Tmax(Up to 15 days)