Effects of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
2026年8月25日 更新者：Vertex Pharmaceuticals Incorporated
A Phase 1, Open-label Drug Interaction Study to Evaluate the Effect of VX-407 on the Pharmacokinetics of Combined Oral Contraceptives
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
研究概览
详细说明
The purpose of the study is to evaluate the pharmacokinetic effects and safety and tolerability of VX-407 when coadministered with oral contraceptives.
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
介入性
注册 (估计的)
148
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：Medical Information
- 电话号码：617-341-6777
- 邮箱：medicalinfo@vrtx.com
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
Key Inclusion Criteria:
- Body mass index (BMI) of 18.0 to 30.0 kilogram per meter square (kg/m^2), inclusive
- A total body weight of greater than (>) 50 kg
Key Exclusion Criteria:
- History of febrile illness within 5 days before the first dose of study drug
- Pregnant, nursing, or planning to become pregnant during the study or within 90 days after the last dose of study drug
Other protocol defined Inclusion/Exclusion criteria will apply.
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：非随机化
- 介入模型：顺序分配
- 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：A部分：带有左甲虫/乙基雌二醇（LNG/EE）的VX-407
参与者将在禁食状态下的第1天和第21天获得单剂量的LNG/EE。
从第8天到第26天，参与者还将每12小时（Q12H）接收VX-407。
|
组合片剂用于口服。
Tablets for Oral Administration.
|
|
实验性的：B部分（可选）：具有非癌/乙基雌二醇（NGM/EE）的VX-407
参与者将在禁食状态下第1和23天获得单剂量的NGM/EE。
参与者还将在禁食状态下从第10至30天开始接收VX-407 Q12H。
|
组合片剂用于口服。
Tablets for Oral Administration.
|
|
实验性的：C部分（可选）：vx-407，带有北inindrone/乙基雌二醇（net/ee）
参与者将在禁食状态下的第1和第19天获得单剂量的净/EE。
参与者还将在禁食状态下从第6天到第22天获得VX-407 Q12H。
|
组合片剂用于口服。
Tablets for Oral Administration.
|
|
实验性的：D部分（可选）：带有苯甲酮/乙基雌二醇的VX-407（DRSP/EE）
参与者将在禁食状态下的第1天和第21天获得一剂DRSP/EE。
参与者还将在禁食状态下从第8天到第26天获得VX-407 Q12H。
|
组合片剂用于口服。
Tablets for Oral Administration.
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of LNG/EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 9 and Day 23 up to Day 31
|
From Day 1 up to Day 9 and Day 23 up to Day 31
|
|
Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of NET and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 5 and Day 19 up to Day 23
|
From Day 1 up to Day 5 and Day 19 up to Day 23
|
|
Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of DRSP and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of LNG/EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
|
Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of norelgestromin (NGMN) and norgestrel (NG) (active metabolites of NGM) and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 9 and Day 23 up to Day 31
|
From Day 1 up to Day 9 and Day 23 up to Day 31
|
|
Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of NET and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 5 and Day 19 up to Day 23
|
From Day 1 up to Day 5 and Day 19 up to Day 23
|
|
Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of DRSP and EE in the Absence and Presence of VX-407
大体时间：From Day 1 up to Day 7 and Day 21 up to Day 27
|
From Day 1 up to Day 7 and Day 21 up to Day 27
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Part A: 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 36
|
From Day 1 up to Day 36
|
|
Part B (Optional): 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 39
|
From Day 1 Up to Day 39
|
|
Part C (Optional): 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 32
|
From Day 1 up to Day 32
|
|
Part D (Optional): 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 36
|
From Day 1 up to Day 36
|
|
Part A: Maximum Observed Plasma Concentration (Cmax) of VX-407
大体时间：Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part B (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
大体时间：Days 11, 17 and 23 up to Day 31
|
Days 11, 17 and 23 up to Day 31
|
|
Part C (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
大体时间：Days 7, 13 and 19 up to Day 23
|
Days 7, 13 and 19 up to Day 23
|
|
Part D (Optional): Maximum Observed Plasma Concentration (Cmax) of VX-407
大体时间：Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part A: Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
大体时间：Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
|
Part B (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
大体时间：Days 11, 17 and 23 up to Day 31
|
Days 11, 17 and 23 up to Day 31
|
|
Part C (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
大体时间：Days 7, 13 and 19 up to Day 23
|
Days 7, 13 and 19 up to Day 23
|
|
Part D (Optional): Area Under the Concentration Versus Time Curve From the Time of Dosing Extrapolated to Infinity (AUC0-inf) of VX-407
大体时间：Days 9, 15 and 21 up to Day 27
|
Days 9, 15 and 21 up to Day 27
|
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。
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28日
初级完成 (估计的)
2027年3月11日
研究完成 (估计的)
2027年3月20日
研究注册日期
首次提交
2026年8月25日
首先提交符合 QC 标准的
2026年8月25日
首次发布 (实际的)
2026年8月28日
研究记录更新
最后更新发布 (实际的)
2026年8月28日
上次提交的符合 QC 标准的更新
2026年8月25日
最后验证
2026年8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
- VX26-407-014
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/our-science/clinical-trials-data-sharing/
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不
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