A Randomized, Double Blind Clinical Trial to Assess Safety, Tolerability and Pharmacokinetics of MK-1708 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 with ≥1 adverse event (AE)
研究概览
简要总结
The purpose of this study is to learn about the safety of MK-1708, and how well elderly people tolerate it. The study will also measure what happens to MK-1708 in a healthy elderly person's body over time (pharmacokinetic or PK study). Researchers will learn if at least 1 dose level of MK-1708 will be safe, well-tolerated, and will be above a certain level in people's blood after 24 hours.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The key inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Has a body mass index (BMI) ≥18 and ≤32 kg/m^2, inclusive
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •Has a history of cancer (malignancy). Participants with definitively treated disease who, in the opinion of the study investigator, are highly unlikely to have a recurrence for the duration of the study may be enrolled at the discretion of the investigator
研究组 & 干预措施
MK-1708 Dosage 1
Participants receive multiple doses of MK-1708 dosage 1.
干预措施: MK-1708 (Drug)
MK-1708 Dosage 2
Participants receive multiple doses of MK-1708 dosage 2.
干预措施: MK-1708 (Drug)
Placebo
Participants receive multiple doses of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with ≥1 adverse event (AE)
时间窗: Up to 14 days after the last dose
Number of participants discontinuing study therapy due to AE
时间窗: Up to ~2 weeks
Area under the plasma concentration-time curve from dosing to 24 hours postdose (AUC0-24) of multiple MK-1708 doses
时间窗: At designated time points up to ~2 weeks
Maximum plasma concentration (Cmax) of multiple MK-1708 doses
时间窗: At designated time points up to ~20 days
Time to maximum plasma concentration (Tmax) of multiple MK-1708 doses
时间窗: At designated time points up to ~20 days
Concentration 24 hours postdose (C24) of multiple MK-1708 doses
时间窗: At designated time points up to ~2 weeks
Apparent oral clearance (CL/F) of multiple MK-1708 doses, at steady state
时间窗: At designated time points up to ~20 days
Apparent volume of distribution (Vz/F) of multiple MK-1708 doses, at steady state
时间窗: At designated time points up to ~20 days
Apparent terminal half-life (t½) of multiple MK-1708 doses
时间窗: At designated time points up to ~20 days
AUC0-24 accumulation ratio of multiple MK-1708 doses
时间窗: At designated time points up to ~2 weeks
Cmax accumulation ratio of multiple MK-1708 doses
时间窗: At designated time points up to ~20 days
C24 accumulation ratio of multiple MK-1708 doses
时间窗: At designated time points up to ~2 weeks
次要结局
未报告次要终点