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

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

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Itraconazole; Drug: BGB-16673; Drug: Phenytoin

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Fortrea Clinical Research Unit Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: BGB-16673 + Phenytoin (CYP3A Inducer); Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673	Drug: BGB-16673; Administered orally; Drug: Phenytoin; Administered orally
Experimental: Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor); Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673	Drug: Itraconazole; Administered orally; Drug: BGB-16673; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673	Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-tlast) of BGB-16673	Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673	Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673		Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673		Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673		Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673		Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Part A and Part B: Number of Participants with Adverse Events (AEs)	Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0	Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Laboratory Values		Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results		Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements		Up to approximately 36 days

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Actual): October 13, 2025
• Study Completion (Actual): October 13, 2025

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Drug-drug interactions; BGB-16673
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Triazoles; Piperazines; Hydantoins; Imidazolidines; Itraconazole; Phenytoin
• Other Study ID Numbers: BGB-16673-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No