RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

A Phase 1, Open-label, Fixed-sequence, Crossover Study to Investigate the Effect of Coadministration of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-16673 in Healthy Participants

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Madison

Fortrea Clinical Research Unit Inc., Madison, Wisconsin, United States, 53704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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).

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

BeiGene,

Study Director, STUDY_DIRECTOR, BeiGene

Study Record Dates

2025-06-16