A Clinical Study to Evaluate the Relative Bioavailability of MK-1403 Formulations Administered to Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of Participants Who Experience an Adverse Event (AE)
研究概览
简要总结
The purpose of this trial is to learn about a trial medicine called MK-1403. Researchers designed MK-1403 to treat a type of heart and blood vessel disease called atherosclerotic cardiovascular disease (ASCVD).
Before giving a trial medicine to people with a health condition, researchers first do clinical trials in healthy people. This trial will help researchers learn about the safety of MK-1403 and if participants tolerate it. Tolerate means participants receive the trial medicine and they do not need to stop taking it due to health problems. The trial will also measure what happens to MK 1403 in a healthy person's body over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is in good health
- •Has a body mass index (BMI) ≥ 18 and ≤ 32 kg/m^2
排除标准
- •Has history of cancer (malignancy)
- •Has a history of significant multiple and/or severe allergies
研究组 & 干预措施
MK-1403 formulation (FM) 1 + additive, Fed
MK-1403 FM 1 + additive tablet administered once orally at study dose after a high-fat meal.
干预措施: MK-1403 formulation (FM) 1 + additive (Drug)
MK-1403 FM2 + additive, Fed
MK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal.
干预措施: MK-1403 FM2 + additive (Drug)
MK-1403 FM1 + additive, Fasted
MK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state.
干预措施: MK-1403 formulation (FM) 1 + additive (Drug)
结局指标
主要结局
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 4 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue the Study Intervention Due to an AE
时间窗: Up to approximately 2 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
时间窗: Predose and at designated timepoints (up to 72 hours postdose)
Blood samples will be collected to determine the AUC0-inf of MK-1403 in plasma.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of MK-1403
时间窗: Predose and at designated timepoints (up to 72 hours postdose)
Blood samples will be collected to determine the AUC0-last of MK-1403 in plasma.
Maximum Plasma Concentration (Cmax) of MK-1403
时间窗: Predose and at designated timepoints (up to 72 hours postdose)
Blood samples will be collected to determine the Cmax of MK-1403 in plasma.
次要结局
未报告次要终点