A Two-Period Study to Evaluate the Effects of Multiple Oral Doses of Itraconazole on the Single Dose PK of MK-1708 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
研究概览
简要总结
The goal of the study is to see what happens to levels of MK-1708 a person's body over time. Researchers will compare what happens to MK-1708 in the body when it is given with or without a medicine called itraconazole.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 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 before randomization
- •Has a body mass index (BMI) ≥18.5 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
研究组 & 干预措施
Period 1: MK-1708
Participants will receive a single oral dose of MK-1708 on Day 1.
干预措施: MK-1708 (Drug)
Period 2: MK-1708 and Itraconazole
A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.
干预措施: MK-1708 (Drug)
Period 2: MK-1708 and Itraconazole
A washout period of at least 10 days will occur between MK-1708 dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, participants will receive itraconazole twice daily on Day 1 and once daily on Days 2 through Day 19. Participants will also receive a single oral dose of MK-1708 on Day 4.
干预措施: Itraconazole (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-1708
时间窗: Predose and at designated timepoints up to approximately 2 weeks postdose
Blood samples will be collected to determine the AUC0-inf of MK-1708.
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 11 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Due to an AE
时间窗: Up to approximately 11 weeks
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study due to an AE will be reported.
次要结局
- Area Under the Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUC0-Last) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)
- Maximum Plasma Concentration (Cmax) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)
- Time to Maximum Plasma Concentration (Tmax) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)
- Plasma Concentration at 24 Hours (C24) of MK-1708(Predose and at designated timepoints up to 24 hours postdose)
- Apparent Clearance (CL/F) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)
- Apparent Terminal Half-life (t1/2) of MK-1708(Predose and at designated timepoints up to approximately 2 weeks postdose)