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A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

2026年7月21日 更新者:BeOne Medicines

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants

This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.

BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.

In this study, we will give BGB-58067 together with two commonly used medicines:

  • Part A: Phenytoin (inducer), which can increase the production of the enzyme, and
  • Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.

研究概览

研究类型

介入性

注册 (估计的)

30

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

学习地点

    • South Australia
      • Adelaide、South Australia、澳大利亚、SA 5000
        • 招聘中
        • CMAX Clinical Research

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:

  • Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
  • Participants must be willing and able to comply with all study requirements.
  • Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the investigator, with additional requirements as follows:

    a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.

  • Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following menarche, and until becoming postmenopausal) unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
  • Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the last dose of BGB-58067. An additional highly effective method of birth control is highly recommended for the duration of the study and for 3 months after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study

Exclusion Criteria:

  • Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
  • Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the study site). Hay fever is not an exclusion criterion unless it is active
  • Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
  • History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.
  • Participants with a history of cholecystectomy or gall stones
  • Poor venous access that limits phlebotomy
  • Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission.

Note: Other protocol-defined Inclusion/Exclusion criteria may 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:并行分配
  • 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:Part A: BGB-58067 + Phenytoin (CYP3A Inducer)
Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.
口服
Administered orally
实验性的:Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)
Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.
口服给药
Administered orally

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067
大体时间:Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8

次要结果测量

结果测量
措施说明
大体时间
Part A and Part B: Number of Participants with Adverse Events (AEs)
大体时间:Up to approximately 30 days
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Up to approximately 30 days

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:Study Director、BeOne Medicines

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6月4日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年5月11日

首先提交符合 QC 标准的

2026年5月11日

首次发布 (实际的)

2026年5月15日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月21日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

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

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

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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