An Open Label, Single-Period, Phase 1 Study To Evaluate The Pharmacokinetics, Excretion Balance And Metabolism Of [14C]-PF04971729 In Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Ertugliflozin half life (t1/2)
研究概览
简要总结
This is single dose study of radiolabeled [14C]-ertugliflozin (PF04971729, MK-8835) in healthy male volunteers to study the absorption, distribution, metabolism and elimination of ertugliflozin.
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 with Body Mass Index of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
排除标准
- •Female participants. Participants enrolled in a previous radionucleotide study or who have received radiotherapy or exposed to significant radiation within 12 months prior to screening
研究组 & 干预措施
[14C]Ertugliflozin
Single dose - oral dosing suspension
干预措施: Ertugliflozin (Drug)
结局指标
主要结局
Ertugliflozin half life (t1/2)
时间窗: Up to 7 Days
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to 7 Days
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]Ertugliflozin (100 µCi).
时间窗: Up to 7 Days
AUC from Hour 0 to infinity (AUCinf) for ertugliflozin
时间窗: Up to 7 Days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
时间窗: Up to 7 Days
Amount of Ertugliflozin and metabolites in plasma, urine, and feces
时间窗: Up to 7 Days
Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin
时间窗: Up to 7 Days
Maximum plasma concentration (Cmax) of ertugliflozin
时间窗: Up to 7 Days
次要结局
未报告次要终点