CClinicalTrials.gg
Sign In
CompletedNCT06906809Updated Aug 24, 2026

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

A Phase 1 interventional study of BGB-16673 and Itraconazole in Healthy Volunteers, sponsored by BeiGene. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by BeiGene · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • BGB-16673
  • Drug-drug interactions
  • Pharmacokinetics
03

In context

Lead sponsor

BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • 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 · Drug: Phenytoin

  • Experimental
    Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor)

    Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673

    Drug: BGB-16673 · Drug: Itraconazole

Interventions

  • DrugBGB-16673

    Administered orally

    Also known as: Tacabrutideg

  • DrugItraconazole

    Administered orally

  • DrugPhenytoin

    Administered orally

06

What researchers measure

Primary outcomes

  1. Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  2. 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

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  3. Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

Secondary outcomes

  1. Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  2. Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  3. Part A and Part B: Apparent Total Clearance (CL/F) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  4. Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-16673

    Time frame: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17

  5. 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

    Time frame: Up to approximately 36 days

  6. Part A and Part B: Number of Participants with Clinically Significant Laboratory Values

    Time frame: Up to approximately 36 days

  7. Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results

    Time frame: Up to approximately 36 days

  8. Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements

    Time frame: Up to approximately 36 days

07

Study locations

1 site
  • Fortrea Clinical Research Unit Inc
    Madison, Wisconsin 53704-2526, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06906809
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
Apr 2, 2025
Start date
Apr 3, 2025
Primary completion
Oct 13, 2025
Completion
Oct 13, 2025
Last update
Aug 24, 2026

Study contacts

Study Director
study director · BeiGene

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

BeiGene

Start the discussion