A Randomized Clinical Study to Evaluate the Impact of Injection Site (Thigh vs Abdomen) on the Pharmacokinetics and Relative Bioavailability of Subcutaneously Injected MK-6194 in Healthy Adult 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
- Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194
研究概览
简要总结
The goal of this study is to learn what happens to MK-6194 in a healthy person's body when different injection sites are used. Researchers will compare what happens to MK-6194 in a healthy person's body when it is injected into the abdomen and when it is injected into the thigh. Researchers think that the average amount of MK-6194 in a person's body over time will be similar when injected into the thigh or abdomen. They also want to learn if it is safe to inject MK-6194 into the abdomen and thigh, and if people tolerate it.
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 50 Years（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
- •Has a body mass index (BMI) within 18 to 35 kg/m2 and weighs at least 50 kg
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
研究组 & 干预措施
Abdomen Injection
Participants will receive a single dose of MK-6194 injected into the abdomen.
干预措施: MK-6194 (Biological)
Thigh Injection
Participants will receive a single dose of MK-6194 injected into the thigh.
干预措施: MK-6194 (Biological)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the AUC0-Last of MK-6194.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the AUC0-Inf of MK-6194.
Maximum Plasma Concentration (Cmax) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Cmax of MK-6194.
Time to Maximum Plasma Concentration (Tmax) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Tmax of MK-6194.
Apparent Clearance (CL/F) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the CL/F of MK-6194.
Apparent Terminal Half-life (t1/2) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the t1/2 of MK-6194.
Apparent Volume of Distribution (Vz/F) of MK-6194
时间窗: At designated timepoints (up to approximately 4 weeks postdose)
Blood samples will be collected to determine the Vz/F of MK-6194.
次要结局
- Number of Participants Who Experience an Adverse Event(Up to approximately 12 weeks)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 12 weeks)