Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants

Launched by BEIGENE · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how two different medications, phenytoin and itraconazole, affect the way a new drug called BGB-16673 is absorbed and eliminated from the body. The study involves healthy volunteers aged 18 to 65 and aims to understand how these medications might change how BGB-16673 works in the body.

To participate, individuals must be in good health and have a body mass index (BMI) between 18 and 32. They cannot have any significant medical conditions or recent infections, and certain surgeries that change how the body absorbs medications will also exclude them from joining. Participants can expect to undergo health screenings and then receive doses of BGB-16673 alongside either phenytoin or itraconazole while being closely monitored for safety and effectiveness. This trial is currently recruiting volunteers, and it’s an important step in learning more about how these drugs interact.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female, of any race, between 18 and 65 years of age
• • In good health, as determined by no clinically significant findings from medical history,12- lead ECG and vital signs measurements, physical examination and clinical laboratory evaluations
• • Body mass index between 18.0 and 32.0kg/m2, inclusive
• Exclusion Criteria:
• • Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee.
• • Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study drug, as determined by the investigator (or designee).
• • History of malignancy, except for appropriately treated carcinoma in situ of the cervix or nonmelanoma skin carcinoma not requiring ongoing systemic treatment.
• • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
• • Participants who have acute gastrointestinal symptoms at the time of screening and or/admission (eg, nausea, vomiting, diarrhea, or heartburn).