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

NCT07590102 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BGB-58067-102
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Healthy Volunteers

Keywords

BGB-58067; Pharmacokinetics; Drug-Drug Interaction (DDI)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (1)

• Part A and Part B: Number of Participants with Adverse Events (AEs)

  Up to approximately 30 days

Study Arms (2)

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.

Drug: BGB-58067; Drug: Phenytoin

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.

Drug: BGB-58067; Drug: Itraconazole

Interventions

BGB-58067 DRUG

Administered orally

Part A: BGB-58067 + Phenytoin (CYP3A Inducer); Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)

Phenytoin DRUG

Administered orally

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

Itraconazole DRUG

Administered orally

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• 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.

Sponsors & Collaborators

• BeOne Medicines: lead

MeSH Terms

Interventions

Phenytoin; Itraconazole

Intervention Hierarchy (Ancestors)

Hydantoins; Imidazolidines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Triazoles; Piperazines

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description