A Study to Evaluate the Pharmacokinetics of Single Dose Formulations of MK-6552 and the Effect of Food in Healthy Study Participants
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Concentration at 8 hours (C8h) of MK-6552 in a Fasted State
研究概览
简要总结
The primary purpose of this study is to learn what happens to levels of MK-6552 in the blood when MK-6552 is given in different forms to healthy adult participants under fasted and fed conditions.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Sequence 1: (Treatment A) → (Treatment B) → (Treatment C) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
Sequence 2: (Treatment B) → (Treatment C) → (Treatment A) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
Sequence 3: (Treatment C) → (Treatment A) → (Treatment B) → (Treatment B) → (Treatment C)
Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
Sequence 4: (Treatment A) → (Treatment C) → (Treatment B) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
Sequence 5: (Treatment B) → (Treatment A) → (Treatment C) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
Sequence 6: (Treatment C) → (Treatment B) → (Treatment A) → (Treatment C) → (Treatment B)
Period 1: Participants receive MK-6552 Treatment C single dose administered orally under fasted conditions (Period 1 = 4 days). Period 2: Participants receive MK-6552 Treatment B single dose administered orally under fasted conditions (Period 2 = 4 days). Period 3: Participants receive MK-6552 Treatment A single dose administered orally under fasted conditions. (Period 3 = 4 days). Period 4: Participants receive MK-6552 Treatment C single dose administered orally under fed conditions (Period 4 = 4 days). Period 5: Participants receive MK-6552 Treatment B single dose administered orally under fed conditions (Period 5 = 4 days). There will be a minimum 3-day washout between periods.
干预措施: MK-6552 (Drug)
结局指标
主要结局
Concentration at 8 hours (C8h) of MK-6552 in a Fasted State
时间窗: 8 hours postdose
Blood samples will be collected to determine the C8h of MK-6552.
Concentration at 16 hours (C16h) of MK-6552 in a Fasted State
时间窗: 16 hours postdose
Blood samples will be collected to determine the C16h of MK-6552.
Area Under the Plasma Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-last) of MK-6552 in a Fasted State
时间窗: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-last of MK-6552.
Area Under the Plasma Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552 in a Fasted State
时间窗: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the AUC0-inf of MK-6552.
Maximum Concentration (Cmax) of MK-6552 in a Fasted State
时间窗: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Cmax of MK-6552.
Time to maximum concentration (Tmax) of MK-6552 in a Fasted State
时间窗: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the Tmax of MK-6552.
Apparent Terminal Half-life (t1/2) of MK-6552 in a Fasted State
时间窗: Predose and at designated timepoints approximately up to 3 days postdose
Blood samples will be collected to determine the t1/2 of MK-6552.
次要结局
- C16h of MK-6552 in a Fed or Fasted State(16 hours postdose)
- Tmax of MK-6552 in a Fed or Fasted State(Predose and at designated timepoints approximately up to 3 days postdose)
- Number of participants with one or more adverse events (AE)(Up to approximately day 35)
- Number of participants discontinuing from study therapy due to AE(Up to approximately day 35)
- Cmax of MK-6552 in a Fed or Fasted State(Predose and at designated timepoints approximately up to 3 days postdose)
- t1/2 of MK-6552 in a Fed or Fasted State(Predose and at designated timepoints approximately up to 3 days postdose)
- AUC0-last of MK-6552 in a Fed or Fasted State(Predose and at designated timepoints approximately up to 3 days postdose)
- AUC0-inf of MK-6552 in a Fed or Fasted State(Predose and at designated timepoints approximately up to 3 days postdose)
- C8h of MK-6552 in a Fed or Fasted State(8 hours postdose)