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

BeOne Medicines1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2026年6月4日最近更新: 2026年7月22日

适应症

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方
入组人数: 30
试验地点: 1
主要终点: Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•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-
•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-
•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

排除标准

•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.

研究组 & 干预措施

Part A: BGB-58067 + Phenytoin (CYP3A Inducer)

Experimental

Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.

干预措施: Phenytoin (Drug)

Part A: BGB-58067 + Phenytoin (CYP3A Inducer)

Experimental

Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.

干预措施: BGB-58067 (Drug)

Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)

Experimental

Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.

干预措施: Itraconazole (Drug)

Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)

Experimental

Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.

干预措施: BGB-58067 (Drug)