A Clinical Trial of MK-8527 and Rifampin in Adult Participants With Latent Tuberculosis Infection (MK-8527-019)
2026年7月31日 更新者：Merck Sharp & Dohme LLC
An Open-label, Phase 1 Study to Characterize the Effects of Rifampin on the Pharmacokinetics of MK-8527 in Adult Participants With Latent Tuberculosis Infection
Researchers are studying MK-8527, a new medicine for preventing HIV-1 (human immunodeficiency virus type 1) infection and want to learn if MK-8527 can be given together with rifampin. Rifampin is commonly used to treat people with latent tuberculosis infection (LTBI).
The main goal of this study is to learn what happens to MK-8527 in the body over time when given with and without the medication rifampin in participants with LTBI.
研究概览
研究类型
介入性
注册 (估计的)
14
阶段
- 阶段1
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
不
描述
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
- Has a diagnosis of untreated latent tuberculosis infection (LTBI)
- Has no symptoms of active tuberculosis (TB)
- Has never received treatment for TB or LTBI
- Other than having LTBI, is in good health
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
- Has a diagnosis of LTBI made in the context of an outbreak/contact-tracing investigation
- Has a current or anticipated immunocompromised state
- Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- Has a history of cancer (malignancy)
- Has a history of active TB
- Has positive test results for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
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：治疗
- 分配：不适用
- 介入模型：单组作业
- 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：MK-8527 + Rifampin
Participants receive single doses of MK-8527 alone and in combination with daily doses of rifampin.
|
口服给药
Administered orally
|
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 |
|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine the AUC0-inf of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
经历不良事件 (AE) 的参与者人数
大体时间：最长约 8 周
|
AE 是参与者发生的任何不良医疗事件，暂时与研究治疗的使用相关，无论是否被认为与研究治疗相关。
将报告经历 AE 的参与者人数。
|
最长约 8 周
|
|
Area Under the Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine AUC0-last of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC0-336) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine AUC0-336 of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Maximum Plasma Concentration (Cmax) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine Cmax of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Time to Maximum Plasma Concentration (Tmax) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine Tmax of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Terminal Elimination Half-Life (T1/2) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine t1/2 of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Clearance (CL/F) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine CL/F of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-8527
大体时间：At designated time points (up to approximately 2 weeks)
|
Blood samples will be collected to determine Vz/F of MK-8527 in plasma.
|
At designated time points (up to approximately 2 weeks)
|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
大体时间：Up to approximately 8 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 treatment due to an AE will be reported.
|
Up to approximately 8 weeks
|
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 (估计的)
2026年9月1日
初级完成 (估计的)
2027年1月19日
研究完成 (估计的)
2027年1月19日
研究注册日期
首次提交
2026年5月15日
首先提交符合 QC 标准的
2026年5月15日
首次发布 (实际的)
2026年5月22日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月31日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 8527-019
- MK-8527-019 (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.