A Randomized, Double-Blind Clinical Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MK-1167 in Healthy Elderly Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Number of Participants Discontinuing Study Treatment due to an AE
研究概览
简要总结
The goal of this study is to learn how safe MK-1167 is in healthy elderly adults and how well people tolerate it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older 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
Panel A
Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16.
干预措施: MK-1167 (Drug)
Panel A
Participants receive a loading dose of MK-1167 or Placebo orally on day 1, followed by a once daily (QD) maintenance dose orally on days 2 to 16.
干预措施: Placebo (Drug)
Panel B
Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16.
干预措施: MK-1167 (Drug)
Panel B
Participants receive a loading dose of MK-1167 or Placebo orally on days 1 to 3, followed by a QD maintenance dose orally on days 4 to 16.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Discontinuing Study Treatment due to an AE
时间窗: Up to approximately 16 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of MK-1167 after Multiple Doses
时间窗: Predose and at designated timepoints up to 24 hours postdose on days 1, 8 and 16
Blood samples will be collected to determine the AUC0-24 of MK-1167.
Maximum Concentration (Cmax) of MK-1167 after Multiple Doses
时间窗: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
Blood samples will be collected to determine the Cmax of MK-1167.
Concentration at 24 hours (C24) of MK-1167 after Multiple Doses
时间窗: 24 hours postdose on days 1, 8 and 16
Blood samples will be collected to determine the C24 of MK-1167.
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to approximately 41 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Time to reach maximum concentration (Tmax) of MK-1167 after Multiple Doses
时间窗: Predose and at designated timepoints up to 24 hours postdose on days 1 and 8 and up to 600 hours postdose on day 16
Blood samples will be collected to determine the Tmax of MK-1167.
Apparent Clearance (CL/F) of MK-1167 after Multiple Doses
时间窗: Predose and at designated timepoints up to 600 hours postdose on day 16
Blood samples will be collected to determine the CL/F of MK-1167.
Volume of Distribution (Vz/F) of MK-1167 at Steady State after Multiple Doses
时间窗: Predose and at designated timepoints up to 600 hours postdose on day 16
Blood samples will be collected to determine the Vz/F of MK-1167.
Apparent Half Life (t½) of MK-1167 after Multiple Doses
时间窗: Predose and at designated timepoints up to 600 hours postdose on day 16
Blood samples will be collected to determine the t½ of MK-1167.
次要结局
未报告次要终点