NCT01932528已完成1 期
A Phase 1, Open-label, Non-randomised, Single-dose Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]-Telotristat Etiprate (LX1606) in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration of LX1606 and LX1033
研究概览
简要总结
To evaluate the metabolism and routes and extent of elimination of telotristat etiprate and its primary metabolite LX1033.
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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects aged 30 to 65 years of age.
- •Male subjects and their partners must agree to use an adequate method of contraception
- •Historically able to produce a minimum of 1 bowel movement every day on most days
排除标准
- •Female subjects
- •Use of any medication or supplement within 5 days prior to Dosing
- •Radiation exposure exceeding 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years
- •Current smokers or the use of cigarettes within 90 days prior to Screening
- •History or renal disease or abnormal kidney function
- •History of hepatic disease
- •Acute diarrhea or constipation within 7 days of dosing
- •Positive urine glucose at Screening
研究组 & 干预措施
500 mg LX606
Experimental
All subjects will receive a single oral 500 mg dose of [14C]-LX1606.
干预措施: 500 mg [14C]-LX1606 (Drug)
结局指标
主要结局
Maximum plasma concentration of LX1606 and LX1033
时间窗: 7 days
次要结局
- Time to maximum plasma concentration of and LX1033(7 days)
- Determination of total radioactivity in blood and plasma(7 days)
- Mass balance recovery of total radioactivity in urine and feces(7 days)
- Metabolite profiling and identification in plasma(7 days)
- Metabolic profiling and identification in urine(7 days)
- Metabolic profiling and identification in feces(7 days)
研究者
研究点 (1)
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