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A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants

2026年8月28日更新者：Bristol-Myers Squibb

A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants

The purpose of this study is to assess the food effect and drug interactions on drug levels of Navlimetostat in health adult female participants

研究概览

地位

尚未招聘

条件

Healthy Female Adults

干预/治疗

研究类型

介入性

注册 (估计的)

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：First line of the email MUST contain NCT # and Site #.

研究联系人备份

姓名：BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
电话号码：855-907-3286
邮箱：Clinical.Trials@bms.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

Inclusion Criteria

Participants must be healthy adult female (as assigned at birth) individuals not of childbearing potential (INOCBP) who have no clinically significant findings on medical history, physical examination (PE), vital signs (VS), 12-lead electrocardiograms (ECGs), or clinical laboratory determinations, as assessed by the investigator.
Participants must have a BMI of 18.0 to 35.0 kg/m2, inclusive.

Exclusion Criteria

Participants must not have any significant acute or chronic medical illness (in the assessment of the investigator).
Participants must not have a history of prolonged bleeding or excessive bruising.
Participants must not have any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status.
Other protocol-defined Inclusion/Exclusion criteria 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）

手臂数量

武器和干预

参与者组/臂	干预/治疗
实验性的：第2部分	药品：咪达唑仑特定日期的特定剂量药品：Navlimetostat 指定日期的指定剂量其他名称： BMS-986504 MRTX-1719
实验性的：第 3 部分	药品：Navlimetostat 指定日期的指定剂量其他名称： BMS-986504 MRTX-1719
实验性的：第 1A 部分	药品：伊曲康唑特定日期的特定剂量药品：Navlimetostat 指定日期的指定剂量其他名称： BMS-986504 MRTX-1719
实验性的：第 1B 部分	药品：利福平特定日期的特定剂量药品：Navlimetostat 指定日期的指定剂量其他名称： BMS-986504 MRTX-1719
实验性的：Part 4	药品：Navlimetostat 指定日期的指定剂量其他名称： BMS-986504 MRTX-1719 药品：Pantoprazole Specified dose on specified days

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
Maximum observed concentration (Cmax) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Area under the concentration-time curve from time zero to 192 hours (AUC(0-192)) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
(AUC(INF)) of Navlimetostat with the coadministration of itraconazole 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of itraconazole 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1B, Part 3, Part 4	Up to approximately 3 weeks
AUC(INF) of Navlimetostat with the coadministration of Rifampin 大体时间：Up to approximately 3 weeks	Part 1B	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Rifampin 大体时间：Up to approximately 3 weeks	Part 1B	Up to approximately 3 weeks
Cmax of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(0-T) of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Midazolam with the coadministration of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Midazolam without the coadministration of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of Navlimetostat with a high fat meal 大体时间：Up to approximately 3 weeks	Part 3	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without a high fat meal 大体时间：Up to approximately 3 weeks	Part 3	Up to approximately 3 weeks
AUC(INF) of Navlimetostat with the coadministration of Pantoprazole 大体时间：Up to approximately 3 weeks	Part 4	Up to approximately 3 weeks
AUC(INF) of Navlimetostat without the coadministration of Pantoprazole 大体时间：Up to approximately 3 weeks	Part 4	Up to approximately 3 weeks
Drug-related AEs 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks

次要结果测量

结果测量	措施说明	大体时间
Adverse events (AEs) 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
Serious adverse events (SAEs) 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
AEs leading to discontinuation of study or study intervention 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in physical examination (PE) 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in vital signs (VS) 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in 12-lead electrocardiograms (ECGs) 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
Number of participants with clinically significant changes in clinical laboratory test results 大体时间：Up to approximately 6 weeks		Up to approximately 6 weeks
AUC(0-T) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
Time of maximum observed concentration (Tmax) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Half-life (T-HALF) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Apparent total body clearance (CLT/F) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Apparent volume of distribution at terminal phase (Vz/F) of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 1A, Part 1B, Part 3, Part 4	Up to approximately 3 weeks
Tmax of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
T-HALF of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
CLT/F of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Vz/F of Midazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Cmax of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(0-T) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(INF) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
AUC(0-192) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
AUC(0-24) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Tmax of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
T-HALF of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
Mean ratio (MR)_Cmax of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(0-T) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(INF) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks		Up to approximately 3 weeks
MR_AUC(0-192) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks	Part 1A	Up to approximately 3 weeks
MR_AUC(0-24) of Navlimetostat Metabolite 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Cmax of Rifampin 大体时间：Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) of Rifampin 大体时间：Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Trough observed concentration (Ctrough) of Rifampin 大体时间：Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Tmax of Rifampin 大体时间：Up to approximately 3 weeks	Part 1A and Part 1B	Up to approximately 3 weeks
Cmax of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(0-T) of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
AUC(INF) of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
Tmax of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
T-HALF of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_Cmax of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(0-T) of 1-hydroxymidazolam 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam with the coadministration of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 weeks
MR_AUC(INF) of 1-hydroxymidazolam without the coadministration of Navlimetostat 大体时间：Up to approximately 3 weeks	Part 2	Up to approximately 3 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。

赞助

Bristol-Myers Squibb

调查人员

研究主任：Bristol-Myers Squibb、Bristol-Myers Squibb

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。

有用的网址

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26日

初级完成 (估计的)

2027年3月25日

研究完成 (估计的)

2027年3月25日

研究注册日期

首次提交

2026年8月28日

首先提交符合 QC 标准的

2026年8月28日

首次发布 (实际的)

2026年9月2日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月28日

最后验证

2026年8月1日

A Study of Navlimetostat (BMS-986504) Drug Interactions and Food Effect in Healthy Participants

A Phase 1, Open-label, Randomized, Pharmacokinetic Study to Assess the Drug Interactions and Food Effect of Navlimetostat (BMS-986504) in Healthy Female Participants

研究概览

地位

条件

干预/治疗

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

研究联系人备份

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

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

次要结果测量

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

出版物和有用的链接

有用的网址

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

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

关键字

其他相关的 MeSH 术语

其他研究编号

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

IPD 共享时间框架

IPD 共享访问标准

IPD 共享支持信息类型

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