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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Itraconazole; Drug: Phenytoin; Drug: BGB-58067

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beonemed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Phenytoin; Administered orally; Drug: BGB-58067; Administered orally
Experimental: Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor); Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.	Drug: Itraconazole; Administered orally; Drug: BGB-58067; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067	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	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	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	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	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	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	Part A: Day 1 and Day 18; Part B: Day 1 and Day 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Number of Participants with Adverse Events (AEs)	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

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-Drug Interaction (DDI); BGB-58067
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Triazoles; Piperazines; Hydantoins; Imidazolidines; Itraconazole; Phenytoin
• Other Study ID Numbers: BGB-58067-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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 Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No