Phase 1Recruiting
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
- Sponsor
- BeOne Medicines (Industry)
- Enrolment
- 30 planned
- Conditions
- Healthy Volunteers
- Interventions
- BGB-58067; Phenytoin; Itraconazole
- Ages
- adults, older adults
- Registry
- NCT07590102
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
- Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
- 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 and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
History
Primary completion expected
Last registry update
Started
Registered