RecruitingPhase 1

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

Australia30 participantsStarted 2026-06-04

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 infe…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8

Trial details

NCT IDNCT07590102

SponsorBeOne Medicines

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Study Director

1-877-828-5568 clinicaltrials@beonemed.com

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