Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Participants
A Phase 1, Open-label Drug-drug Interaction Study to Evaluate the Effects of Efavirenz on the Pharmacokinetics of Suzetrigine in Healthy Subjects
研究概览
详细说明
The study is being conducted to evaluate the effects of efavirenz on the PK of SUZ in healthy participants and consists of Screening Phase, Treatment Phase and Safety Follow-up Phase. Participants will receive study medication for a duration of 30 days.
Note: This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Utah
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Salt Lake City、Utah、美国、84124
- ICON - Utah - Salt Lake City Office
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Key Inclusion Criteria:
- Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2)
- A total body weight of greater than (>) 50 kg
- Males and females of non-childbearing potential
Key Exclusion Criteria:
- History of any illness or any clinical condition that may confound the results of the study or pose an additional risk in administering study drug to the participant
- History of febrile illness or other acute illness that has not fully resolved within 5 days before the first dose of study drug
- Any condition possibly affecting drug absorption
Other protocol defined Inclusion/Exclusion criteria may apply.
学习计划
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 |
|---|---|
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实验性的：SUZ and Efavirenz
Participants will receive a single dose of SUZ on Days 1 through 15.
Participants will also receive a single dose of SUZ in the morning followed by a single dose of efavirenz in the evening on Days 16 through 30.
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Tablet for oral administration.
其他名称：
Tablet for oral administration.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Maximum Observed Plasma Concentration (Cmax) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
大体时间：Day 15 and Day 30
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Day 15 and Day 30
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Area Under the Concentration Versus Time Curve During a Dosing Interval (AUCτ) of SUZ and its Metabolite in the Absence and Presence of Efavirenz
大体时间：Day 15 and Day 30
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Day 15 and Day 30
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：From Day 1 up to Day 46
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From Day 1 up to Day 46
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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
- VX24-548-018
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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.