An Open-Label, Phase 1 Study to Characterize the Effects of Belzutifan on the Pharmacokinetics of a MATE1/2K Substrate, Metformin, in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma
研究概览
简要总结
The goal of this study is to learn how belzutifan (MK-6482) affects the levels of metformin in a healthy person's body over time. Researchers will study levels of metformin in the blood and urine in healthy volunteers after taking metformin alone (Period 1) and metformin with belzutifan (Period 2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Metformin
On Day 1 of Period 1, a single dose of metformin will be administered.
干预措施: Metformin (Drug)
Belzutifan with Metformin
In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4.
干预措施: Metformin (Drug)
Belzutifan with Metformin
In Period 2, belzutifan will be administered every day for 5 consecutive days with a single dose of metformin coadministered on Day 4.
干预措施: Belzutifan (Drug)
结局指标
主要结局
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Metformin in Plasma
时间窗: At designated timepoints (up to approximately 48 hours post-dose metformin)
Blood samples will be collected to determine the AUC0-inf of metformin in plasma.
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 4 weeks)
- Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Metformin(At designated timepoints (up to approximately 24 hours post-dose metformin))
- Maximum Observed Concentration (Cmax) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Plasma Drug Concentration of Metformin at Hour 24 (C24)(24 hours post-dose metformin)
- Time to Maximum Concentration (Tmax) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Number of Participants Who Discontinue Study Drug Due to an AE(Up to approximately 2 weeks)
- Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Apparent Terminal Half-life (t1/2) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Apparent Clearance (CL/F) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Total Amount of Metformin Excreted Unchanged in the Urine(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Renal Clearance of Metformin(At designated timepoints (up to approximately 48 hours post-dose metformin))
- Percentage of Metformin Excreted Unchanged in Urine(At designated timepoints (up to approximately 48 hours post-dose metformin))