An Open-label, Phase 1 Study to Characterize the Effects of Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) on the Pharmacokinetics of MK-8527 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC)
研究概览
简要总结
The goal of this study is to learn what happens to MK-8527 in a healthy person's body over time, called a pharmacokinetic (PK) study. Researchers want to learn if there is a difference in the healthy person's body when MK-8527 is taken as a single dose (Treatment A) or with the medication Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) (Treatment B).
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The main inclusion criteria include but are not limited to the following:
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior
- •Has body mass index (BMI) ≥18 and ≤32.0 kg/m^2
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History of low bone density, renal impairment, Fanconi syndrome, autoimmune disorders (such as Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis), liver disease
- •History of cancer (malignancy)
- •Positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV)
研究组 & 干预措施
Treatment A: MK-8527
Participants receive a single dose of MK-8527.
干预措施: MK-8527 (Drug)
Treatment B: MK-8527 + FTC/TDF
Participants receive FTC/TDF then MK-8527.
干预措施: MK-8527 (Drug)
Treatment B: MK-8527 + FTC/TDF
Participants receive FTC/TDF then MK-8527.
干预措施: FTC/TDF (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity after single dosing (AUC0-Inf) of MK-8527-Triphosphate (TP) in peripheral blood mononuclear cell (PBMC)
时间窗: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the AUC0-Inf of MK-8527-TP in PBMC.
Area Under the Concentration-Time Curve from Time 0 to Last quantifiable sample (AUC0-last) of MK-8527-TP in PBMC
时间窗: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the AUC0-last of MK-8527-TP in PBMC.
Drug Concentration at 672 Hours (C672) of MK-8527-TP in PBMC
时间窗: Pre-dose and at designated time points up to 672 hours post dose
Blood samples will be collected to determine the C672 of MK-8527-TP in PBMC.
Maximum Plasma Concentration (Cmax) of MK-8527-TP in PBMC
时间窗: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Cmax of MK-8527-TP in PBMC.
Time to Maximum Plasma Concentration (Tmax) of MK-8527-TP in PBMC
时间窗: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the Tmax of MK-8527-TP in PBMC.
Apparent Terminal Half-life (t1/2) of MK-8527-TP in PBMC
时间窗: Pre-dose and at designated time points up to 840 hours post dose
Blood samples will be collected to determine the t1/2 of MK-8527-TP in PBMC.
次要结局
- AUC0-Inf of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- AUC0-last of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- Cmax of of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- Tmax of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- t1/2 of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- Apparent Clearance (CL/F) of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- Apparent volume of distribution during terminal phase (Vz/F) of MK-8527 in plasma(Pre-dose and at designated time points up to 120 hours post dose)
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 111 days)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 43 days)