A Two-Part Clinical Study to Evaluate the Effect of Multiple Doses of MK-2828 on Rosuvastatin (Part 1) and Furosemide (Part 2) in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin
研究概览
简要总结
Researchers are looking for other ways to treat people who have heart failure with preserved ejection fraction (HFpEF). HFpEF is a type of heart failure where the heart becomes stiff and does not relax properly. MK-2828 is a study medicine designed to treat HFpEF.
The main goal of the study is to learn if MK-2828 affects what happens to rosuvastatin or furosemide in the body.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 24 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health
- •Has a body mass index (BMI) ≥18 and ≤32 kg/m^2
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- •Has a history of cancer (malignancy)
研究组 & 干预措施
Rosuvastatin + MK-2828
Participants receive rosuvastatin and MK-2828 orally.
干预措施: MK-2828 (Drug)
Furosemide + MK-2828
Participants receive furosemide and MK-2828 orally.
干预措施: Furosemide (Drug)
Furosemide + MK-2828
Participants receive furosemide and MK-2828 orally.
干预措施: MK-2828 (Drug)
Rosuvastatin + MK-2828
Participants receive rosuvastatin and MK-2828 orally.
干预措施: Rosuvastatin (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Rosuvastatin
时间窗: At designated time points (up to approximately 2 weeks)
Blood samples will be collected to determine the AUC0-inf of rosuvastatin.
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Furosemide
时间窗: At designated time points (up to approximately 2 weeks)
Blood samples will be collected to determine the AUC0-inf of furosemide.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 1 month)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 2 weeks)
- Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Furosemide(At designated time points (up to approximately 2 weeks))
- Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Rosuvastatin(At designated time points (up to approximately 24 hours))
- Area Under the Concentration-Time Curve from Time 0 to 24 Hours Postdose (AUC0-24) of Furosemide(At designated time points (up to approximately 24 hours))
- Maximum Plasma Concentration (Cmax) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Maximum Plasma Concentration (Cmax) of Furosemide(At designated time points (up to approximately 2 weeks))
- Time of the Maximum Plasma Concentration (Tmax) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Time of the Maximum Plasma Concentration (Tmax) of Furosemide(At designated time points (up to approximately 2 weeks))
- Terminal Half-life (t1/2) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Terminal Half-life (t1/2) of Furosemide(At designated time points (up to approximately 2 weeks))
- Apparent Total Plasma Clearance (CL/F) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Apparent Total Plasma Clearance (CL/F) of Furosemide(At designated time points (up to approximately 2 weeks))
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Rosuvastatin(At designated time points (up to approximately 2 weeks))
- Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) of Furosemide(At designated time points (up to approximately 2 weeks))