A Clinical Study of MK-8527 in Healthy Participants (MK-8527-021)
2026年9月2日 更新者：Merck Sharp & Dohme LLC
An Open-label, Phase 1 Study to Individually Characterize the Food Effect, the Drug-Drug Interaction Effect of OAT Inhibition, and the Drug-Drug Interaction Effect of P-glycoprotein Inhibition on the Pharmacokinetics of MK-8527 in Healthy Adult Participants
Researchers are studying a medicine called MK-8527 to learn how it behaves in the body of healthy adults.
The goal of this study is to learn about the effect of MK-8527 when it is taken with food or with other medicines. Researchers also want to learn about the safety of MK-8527 and if people tolerate it. Tolerate means participants will receive treatment in the trial unless they need to stop it due to health problems.
研究概览
研究类型
介入性
注册 (实际的)
44
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Florida
-
Daytona Beach、Florida、美国、32117
- Fortrea Clinical Research Unit Inc ( Site 0001)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- Be in good health
- Has a body mass index (BMI) between 18 and 32 kg/m^2, inclusive
Exclusion Criteria:
- Has an estimated glomerular filtration rate (eGFR) ≤90 mL/min/1.73 m^2
- 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 stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
- Has a history of cancer (malignancy)
- Is taking any medication that contains emtricitabine (FTC) or lamivudine (3TC)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Part 1: MK-8527
Participants will receive a single dose of MK-8527 with food and a single dose of MK-8527 without food.
|
口服平板电脑
|
|
实验性的：Part 2: MK-8527 + Probenecid
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with probenecid.
|
口服平板电脑
Oral tablet
|
|
实验性的：Part 3: MK-8527 + Itraconazole
Participants will receive a single dose of MK-8527 alone and a single dose of MK-8527 in combination with itraconazole.
|
口服溶液
口服平板电脑
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to Infinity (AUC0-inf) of MK-8527 in Plasma With and Without Food
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: AUC0-inf of MK-8527 in Plasma With and Without Probenecid
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: AUC0-inf of MK-8527 in Plasma With and Without Itraconazole
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-inf of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Part 1: Area Under the Concentration Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-8527 in Plasma With and Without Food
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Time to Maximum Plasma Concentration (Tmax) of MK-8527 in Plasma With and Without Food
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Maximum Plasma Concentration (Cmax) of MK-8527 in Plasma With and Without Food
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Apparent Terminal Half-life (t1/2) of MK-8527 in Plasma With and Without Food
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 1: Number of Participants Who Experience an Adverse Event (AE)
大体时间：Up to approximately 43 days
|
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 AE will be reported.
|
Up to approximately 43 days
|
|
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 43 days
|
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 treatment due to an AE will be reported.
|
Up to approximately 43 days
|
|
Part 2: AUC0-336 of MK-8527 in Plasma With and Without Probenecid
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Tmax of MK-8527 in Plasma with and without Probenecid
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Cmax of MK-8527 in Plasma With and Without Probenecid
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Probenecid
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent terminal t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 2: Urine Concentration at 72 Hours of MK-8527
大体时间：At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 2: Renal Clearance of MK-8527
大体时间：At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the renal clearance of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 2: Number of Participants Who Experience an AE
大体时间：Up to approximately 43 days
|
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 AE will be reported.
|
Up to approximately 43 days
|
|
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 43 days
|
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 treatment due to an AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: AUC0-336 of MK-8527 in Plasma With and Without Itraconazole
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected at multiple time points to estimate AUC0-336 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Tmax of MK-8527 in Plasma With and Without Itraconazole
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Tmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Cmax of MK-8527 in Plasma With and Without Itraconazole
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the Cmax of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Apparent Terminal t1/2 of MK-8527 in Plasma With and Without Itraconazole
大体时间：Predose and at designated timepoints (up to 336 hours postdose)
|
Blood samples will be collected to estimate the apparent t1/2 of MK-8527 in plasma.
|
Predose and at designated timepoints (up to 336 hours postdose)
|
|
Part 3: Urine Concentration at 72 Hours of MK-8527
大体时间：At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the urine concentration of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Renal Clearance of MK-8527
大体时间：At designated timepoints (up to 72 hours postdose)
|
Urine samples will be collected to estimate the renal clearance of MK-8527.
|
At designated timepoints (up to 72 hours postdose)
|
|
Part 3: Number of Participants Who Experience an AE
大体时间：Up to approximately 43 days
|
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 AE will be reported.
|
Up to approximately 43 days
|
|
Part 3: Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 43 days
|
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 treatment due to an AE will be reported.
|
Up to approximately 43 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Medical Director、Merck Sharp & Dohme LLC
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年6月30日
初级完成 (估计的)
2026年10月9日
研究完成 (估计的)
2026年10月9日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年9月3日
上次提交的符合 QC 标准的更新
2026年9月2日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 8527-021
- MK-8527-021 (其他标识符：MSD)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.