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

Last updated: November 20, 2025
Sponsor: BeiGene
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

BGB-16673

Itraconazole

Phenytoin

Clinical Study ID

NCT06906809
BGB-16673-105
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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

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 medicalhistory,12- lead ECG and vital signs measurements, physical examination and clinicallaboratory evaluations

  • Body mass index between 18.0 and 32.0kg/m2, inclusive

Exclusion

Exclusion Criteria:

  • Significant history or clinical manifestation of any metabolic, allergic,dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, asdetermined by the investigator or designee.

  • Evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeksprior to the first dose of study drug, as determined by the investigator (ordesignee).

  • History of malignancy, except for appropriately treated carcinoma in situ of thecervix or nonmelanoma skin carcinoma not requiring ongoing systemic treatment.

  • History of stomach or intestinal surgery or resection that would potentially alterabsorption and/or excretion of orally administered drugs (uncomplicated appendectomyand hernia repair are allowed).

  • Participants who have acute gastrointestinal symptoms at the time of screening andor/admission (eg, nausea, vomiting, diarrhea, or heartburn).

Study Design

Total Participants: 37
Treatment Group(s): 3
Primary Treatment: BGB-16673
Phase: 1
Study Start date:
April 03, 2025
Estimated Completion Date:
October 13, 2025

Connect with a study center

  • Fortrea Clinical Research Unit Inc

    Madison, Wisconsin 53704-2526
    United States

    Site Not Available

  • Fortrea Clinical Research Unit Inc.

    Madison, Wisconsin 53704
    United States

    Active - Recruiting

  • Fortrea Clinical Research Unit Inc

    Madison 5261457, Wisconsin 5279468 53704-2526
    United States

    Site Not Available

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