A Two-Period, Open-label, Fixed-Sequence Study to Evaluate the Single-Dose Pharmacokinetics of Two Formulations of MK-1167 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167
研究概览
简要总结
Researchers are looking for new ways to treat Alzheimer's disease (AD). AD is a brain disease that causes a gradual decline in memory, thinking, and ability to carry out daily tasks. MK-1167 is a study medicine designed to treat symptoms of AD. Before giving a study medicine to people with a health condition, researchers first do studies in healthy people to find a safe dose of the study medicine.
The goals of the trial are to learn:
- What happens to different forms of MK-1167 in a healthy person's body over time
- About the safety of MK-1167 and if people tolerate it
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Is in good health
- •Has a body mass index (BMI) ≥18 and ≤ 32 kg/m^2, inclusive
排除标准
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- •Is a smoker and/or has used nicotine or nicotine-containing products within the past 3 months.
研究组 & 干预措施
Arm 1: MK-1167 Form 2
Participants receive MK-1167 Form 2 orally.
干预措施: MK-1167 (Drug)
Arm 2: MK-1167 Form 1
Participants receive MK-1167 Form 1 orally.
干预措施: MK-1167 (Drug)
结局指标
主要结局
Area Under the Curve from Time 0 to Infinity (AUC0-inf) of MK-1167
时间窗: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-inf of MK-1167.
Maximum Plasma Concentration (Cmax) of MK-1167
时间窗: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the Cmax of MK-1167.
Area Under the Curve from Time 0 to Last Measurable Concentration (AUC0-last) of MK-1167
时间窗: At designated time points (up to approximately 21 days)
Blood samples will be collected to determine the AUC0-last of MK-1167.
次要结局
- Area Under the Curve from Time 0 to 24 hours (AUC0-24) of MK-1167(At designated time points (up to approximately 24 hours))
- Concentration at 24 hours (C24) of MK-1167(At designated time points (up to approximately 24 hours))
- Time to Maximum Serum Concentration (Tmax) of MK-1167(At designated time points (up to approximately 21 days))
- Apparent Terminal Half-life (t1/2) of MK-1167(At designated time points (up to approximately 21 days))
- Apparent Clearance after Nonintravenous Administration (CL/F) of MK-1167(At designated time points (up to approximately 21 days))
- Apparent Volume of Distribution during Terminal Phase (Vz/F) of MK-1167(At designated time points (up to approximately 21 days))
- Number of Participants Who Experience One or More Adverse Events (AEs)(Up to approximately 78 days)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 36 days)