Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- To asses the PK (AUC, Cmax) of a single oral dose
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of [14C] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.
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
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy Male subjects
- •Ages 18-50 years
- •Body weight of at least 110 lbs (50kg)
- •BMI of 18 to 32 kg/m^2
- •non-smoking
排除标准
- •Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
- •gastrointestinal disease including gastrointestinal surgery
- •constipation or irregular bowel movements
研究组 & 干预措施
Single oral dose of [14C] BMS 955176
A single 180 mg oral dose of [14C] BMS-955176 containing approximately 80 microcurie of total radioactivity.
干预措施: BMS-955176 (Drug)
Nasoduodenal (ND) Tube Cohort
A single dose of [14C] BMS 955176 on Day 1 with ND placement 1 hour post dose to facilitate continuous bile collection though 8 hours post dose.
干预措施: BMS-955176 (Drug)
结局指标
主要结局
To asses the PK (AUC, Cmax) of a single oral dose
时间窗: Day 1 through Day 13 (predose to 288 hours)
Serial blood samples for PK parameters determined from plasma concentration versus time
To estimate extent of elimination of a single oral dose (% TRA recovery)
时间窗: Day 1 through Day 13 (predose to 288 hours)
Sample of urinary/fecal/bile will be collected for determining total recovery.
次要结局
- Safety Assessment(Day 1 through Day 13)