Status:
COMPLETED
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
Lead Sponsor:
BeiGene
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effect of coadministration of phenytoin or itraconazole on the pharmacokinetics of BGB-16673 in healthy participants.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2025
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT06906809
Start Date
April 3 2025
End Date
October 13 2025
Last Update
November 21 2025
Active Locations (1)
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1
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704-2526