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
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
注册 (估计的)
阶段
- 阶段1
联系人和位置
学习联系方式
- 姓名:Study Director
- 电话号码:1-877-828-5568
- 邮箱:clinicaltrials@beonemed.com
学习地点
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South Australia
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Adelaide、South Australia、澳大利亚、SA 5000
- 招聘中
- CMAX Clinical Research
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
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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.
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口服
Administered orally
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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.
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口服给药
Administered orally
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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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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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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
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Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Part A and Part B: Number of Participants with Adverse Events (AEs)
大体时间:Up to approximately 30 days
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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
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Up to approximately 30 days
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合作者和调查者
调查人员
- 研究主任:Study Director、BeOne Medicines
研究记录日期
研究主要日期
学习开始 (实际的)
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
其他研究编号
- BGB-58067-102
计划个人参与者数据 (IPD)
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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
IPD 共享访问标准
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
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