A Study of Ulonivirine (MK-8507) and Methadone in Healthy Volunteers (MK-8507-019)
2026年8月21日 更新者：Merck Sharp & Dohme LLC
A Clinical Trial to Study the Effect of a Single Dose of Ulonivirine on the Pharmacokinetics of Methadone
This study is designed to determine the effect of ulonivirine (MK-8507) on methadone in the body.
Participants will take methadone alone and then methadone with ulonivirine to see if ulonivirine changes how the body processes methadone.
研究概览
研究类型
介入性
注册 (估计的)
14
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。
学习联系方式
- 姓名：Toll Free Number
- 电话号码：1-888-577-8839
- 邮箱：Trialsites@merck.com
学习地点
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Alabama
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Anniston、Alabama、美国、36207
- Pinnacle Research Group ( Site 0002)
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接触：
- Study Coordinator
- 电话号码：256-236-0055
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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
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria
The main Inclusion Criteria include but are not limited to:
- Is in good health
- Has a body mass index (BMI) between >18 and ≤40 kg/m^2
- Is reliably participating in a methadone maintenance program for at least 2 months prior to Day 1 and is on a documented stable dose of methadone for at least 14 days prior to Day 1
Exclusion Criteria
The main Exclusion Criteria include but are not limited to:
- Has a history of cancer (malignancy)
- Has a history of significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food
- Has tested positive human immunodeficiency virus (HIV) or for a sexually transmitted infection at screening
- Is under the age of legal consent
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：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 |
|---|---|
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实验性的：Methadone + Ulonivirine
Participants receive a stable dose of methadone orally from Day -14 through Day 16.
Methadone is co-administered with one dose of oral ulonivirine on Day 2.
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Oral Tablet
其他名称：
Oral (per local guidelines)
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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 |
|---|---|---|
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Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone
大体时间：Up to 24 hours post-dose
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The AUC0-24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized AUC0-24 of S-Methadone
大体时间：Up to 24 hours post-dose
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The AUC0-24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone
大体时间：Up to 24 hours post-dose
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The Cmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone
大体时间：24 hours post-dose
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The C24 of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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24 hours post-dose
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Time to Maximum Plasma Concentration (Tmax) of R-Methadone
大体时间：Up to 24 hours post-dose
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The Tmax of R-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized Cmax of S-Methadone
大体时间：Up to 24 hours post-dose
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The Cmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized C24 of S-Methadone
大体时间：24 hours post-dose
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The C24 of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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24 hours post-dose
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Tmax of S-Methadone
大体时间：Up to 24 hours post-dose
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The Tmax of S-methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized AUC0-24 of Total Methadone
大体时间：Up to 24 hours post-dose
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The AUC0-24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Dose-Normalized Cmax of Total Methadone
大体时间：Up to 24 hours post-dose
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The Cmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
|
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Dose-Normalized C24 of Total Methadone
大体时间：24 hours post-dose
|
The C24 of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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24 hours post-dose
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Tmax of Total Methadone
大体时间：Up to 24 hours post-dose
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The Tmax of total methadone will be determined on Day 1 (methadone) and Day 2 (methadone + ulonivirine).
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Up to 24 hours post-dose
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Number of Participants With Adverse Events (AEs) Following Methadone + Ulonivirine Coadministration
大体时间：Up to 16 Days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants experiencing an AE following coadministration of methadone and ulonivirine will be presented.
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Up to 16 Days
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Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and Ulonivirine
大体时间：Up to 16 Days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
The number of participants discontinuing study therapy due to an AE following coadministration of methadone and ulonivirine will be presented.
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Up to 16 Days
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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8月17日
初级完成 (估计的)
2027年1月15日
研究完成 (估计的)
2027年1月15日
研究注册日期
首次提交
2026年5月12日
首先提交符合 QC 标准的
2026年5月12日
首次发布 (实际的)
2026年5月19日
研究记录更新
最后更新发布 (实际的)
2026年8月24日
上次提交的符合 QC 标准的更新
2026年8月21日
最后验证
2026年8月1日
更多信息
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.