A Study to Investigate the Absorption, Metabolism, Excretion and Mass Balance After Administration of a Single Dose of [14C]MK-0941
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
研究概览
简要总结
A single dose, open label study to characterize the routes of elimination and determine the mass balance of MK-0941. A single 40 mg dose of MK-0941 will be given orally to male participants with type 2 diabetes. After drug administration, blood, urine, and fecal samples will be collected to determine relative quantities of 14C-labeled MK-0941.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject has been diagnosed with type 2 diabetes, and is being treated with diet and exercise or with an oral anti-hyperglycemic agent
- •Subject is willing to follow the American Heart Association diet and exercise program throughout the study
- •Subject is a nonsmoker and/or has not used nicotine products for at least 6 months
排除标准
- •Subject has a history of stroke, seizures, or major neurological disorder
- •Subject has a history of neoplastic disease
- •Subject has recently had abnormal bowel habits, such as diarrhea, loose stools or constipation
- •Subject has a history of type 1 diabetes mellitus
- •Subject has received insulin within the past 12 weeks
- •Subject has a recent history of eye infection
- •Subject has been diagnosed with glaucoma or is blind
- •Subject consumes more than 3 alcoholic beverages per day
- •Subject consumes more than 6 servings of coffee, tea, cola per day
- •Subject has had major surgery, donated or lost blood in the past 4 weeks
- •Subject has multiple or severe allergies to any food or drugs
研究组 & 干预措施
MK-0941
MK-0941
干预措施: MK-0941 (Drug)
结局指标
主要结局
Mean Percent of Dose Recovered in Urine and Feces Following a Single Oral Dose of [^14C]MK-0941 (160 µCi).
时间窗: Up to 168 hours after study drug administration
Urine was collected at predose, 0 to 4, 4 to 8, 8 to 12, and 12 to 24 hr postdose, and at 24 hr intervals through subject discharge. Feces were collected at pre-dose and at 24 hr intervals through subject discharge. Subjects were discharged when the total recovery in urine and feces ≥90% of the administered dose or the recovery in urine and feces for two consecutive 24-hr intervals was ≤ 1%.
次要结局
- Number of Participants Who Experienced An Adverse Event(Up to 14 days after study drug administration)
- Number of Participants Who Discontinued the Study Due to An Adverse Event(Up to 14 days after study drug administration)