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

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 31 days later Sep 30, 2026 → Oct 31, 2026
See other at-risk trials from BeOne Medicines

Record History

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  1. Primary and study completion pushed from Sep 30, 2026 to Oct 31, 2026
  2. Primary endpoints: details revised at 3 of 7 entries
    • Eligibility criteria expanded, about 12 words
    • Site details revised
  3. Re-verified, no change to tracked fieldsv4
  4. Study site revisedv3
  5. Recruitment opened
    • Study sites: 0 to 1
    • Start date: Jun 1, 2026 to Jun 4, 2026
    v2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07590102
Lead Sponsor BeOne Medicines
Conditions
(from sponsor)		 Healthy Volunteers
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov