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 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-05-15
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
Interventions
- DRUG
-
BGB-58067
Administered orally
- DRUG
-
Phenytoin
Administered orally
- DRUG
-
Itraconazole
Administered orally
Sponsors & Collaborators
-
BeOne Medicines
lead INDUSTRY
Principal Investigators
-
Study Director · BeOne Medicines
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-01
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
- FDA Drug
- Yes
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