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

2026年9月30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

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

80

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

学习地点

  • 加拿大
    • Quebec
      • Québec、Quebec、加拿大、G1P 0A2
        • 招聘中
        • Syneos Health Clinique; Inc.
        • 接触：
          • Lidia Facchinelli, Site 0001

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

18年 至 55年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

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）

武器和干预

参与者组/臂
干预/治疗
实验性的：第2部分
药品：Navlimetostat

Specified dose on specified days

其他名称：
  • BMS-986504
  • MRTX-1719
药品：Midazolam

Specified dose on specified days
实验性的：第 3 部分
药品：Navlimetostat

Specified dose on specified days

其他名称：
  • BMS-986504
  • MRTX-1719
实验性的：第 1A 部分
药品：Navlimetostat

Specified dose on specified days

其他名称：
  • BMS-986504
  • MRTX-1719
药品：Itraconazole

Specified dose on specified days
实验性的：第 1B 部分
药品：Navlimetostat

Specified dose on specified days

其他名称：
  • BMS-986504
  • MRTX-1719
药品：Rifampin

Specified dose on specified days
实验性的：Part 4
药品：Navlimetostat

Specified dose on specified days

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
Drug-related AEs
大体时间：Up to approximately 6 weeks
Up to approximately 6 weeks
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

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
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
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
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
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
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 (实际的)

2026年8月31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10月5日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年9月1日

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

  • CA240-0050

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

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD 共享时间框架

See Plan Description

IPD 共享访问标准

See Plan Description

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

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.

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