An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-0616 in Healthy Participants
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
- Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
研究概览
简要总结
The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.
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 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Is in good health.
- •Has a body mass index ≥18 and ≤32 kg/m^2, inclusive.
排除标准
- •Has a history of cancer.
- •Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.
研究组 & 干预措施
[¹⁴C]Enlicitide chloride
Participants will receive a single dose of [¹⁴C]enlicitide chloride on Day 1.
干预措施: [¹⁴C]Enlicitide chloride (Drug)
结局指标
主要结局
Cumulative Amount of Radioactivity Excreted in Urine (Aeu)
时间窗: At designated timepoints (up to 15 days)
Urine samples will be collected to determine the Aeu of \[¹⁴C\]enlicitide chloride.
Cumulative Amount of Radioactivity Excreted in Feces (Aef)
时间窗: At designated timepoints (up to 15 days)
Fecal samples will be collected to determine the Aef of \[¹⁴C\]enlicitide chloride.
Cumulative Percentage of Radioactivity Excreted in Urine (feu)
时间窗: At designated timepoints (up to 15 days)
Urine samples will be collected to determine the feu of \[¹⁴C\]enlicitide chloride.
Cumulative Percentage of Radioactivity Excreted in Feces (fef)
时间窗: At designated timepoints (up to 15 days)
Fecal samples will be collected to determine the fef of \[¹⁴C\]enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.
Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.
Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Cmax of enlicitide chloride.
Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the t1/2 of enlicitide chloride.
Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Tmax of enlicitide chloride.
Plasma Total Reactivity: AUC0-t
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-t of total reactivity.
Plasma Total Reactivity: AUC0-inf
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the AUC0-inf of total reactivity.
Plasma Total Reactivity: Cmax
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Cmax of total reactivity.
Plasma Total Reactivity: t1/2
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the t1/2 of total reactivity.
Plasma Total Reactivity: Tmax
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the Tmax of total reactivity.
Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x)
时间窗: At designated timepoints (up to 15 days)
Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 29 days)
- Number of Participants Who Discontinue the Study Due to an AE(Up to approximately 29 days)