Healthy VolunteersPhase 1NCT06906809
Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants
A Phase 1 study testing BGB-16673, Itraconazole and Phenytoin in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BGB-16673, Itraconazole and Phenytoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2025to 13 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Fortrea Clinical Research Unit Inc
Madison, Wisconsin, 53704-2526
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- BGB-16673, Itraconazole, Phenytoin
- Keywords
- BGB-16673, Drug-drug interactions, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-16673Drug
Also called Tacabrutideg
Administered orally
ItraconazoleDrug
Administered orally
PhenytoinDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: BGB-16673 + Phenytoin (CYP3A Inducer) | Experimental | Participants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 Receives: Drug: BGB-16673; Drug: Phenytoin |
| Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) | Experimental | Participants will receive multiple doses of Itraconazole to determine its effect on BGB-16673 Receives: Drug: BGB-16673; Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-16673
Measured: 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
Measured: 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
Measured: Part A: Day 1 and Day 20; Part B: Day 1 and Day 17
Secondary outcomes (8)
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-16673
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Laboratory Values
Measured: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results
Measured: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements
Measured: Up to approximately 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start3 Apr 2025
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906809
- Sponsor's protocol ID
- BGB-16673-105
- Status last verified
- Aug 2026
- First submitted
- 26 Mar 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06906809
- Acronym / sponsor ID
- BGB-16673-105
- Conditions
- Healthy Volunteers
- Keywords
- BGB-16673, Drug-drug interactions, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: BGB-16673 + Phenytoin (CYP3A Inducer) | Experimental | Drug: BGB-16673, Drug: PhenytoinParticipants will receive multiple doses of Phenytoin to determine its effect on BGB-16673 |
| Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) | Experimental | Drug: BGB-16673, Drug: ItraconazoleParticipants will receive multiple doses of Itraconazole to determine its effect on BGB-16673 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BGB-16673Also: TacabrutidegAdministered orally | Drug | Part A: BGB-16673 + Phenytoin (CYP3A Inducer), Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) |
| ItraconazoleAdministered orally | Drug | Part B: BGB-16673 + Itraconazole (CYP3A Inhibitor) |
| PhenytoinAdministered orally | Drug | Part A: BGB-16673 + Phenytoin (CYP3A Inducer) |
Primary outcome
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
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
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
8 secondary outcomes
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
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
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
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
Part A and Part B: Number of Participants with Adverse Events (AEs)
Time frame: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Laboratory Values
Time frame: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Electrocardiogram (ECG) results
Time frame: Up to approximately 36 days
Part A and Part B: Number of Participants with Clinically Significant Vital Sign Measurements
Time frame: Up to approximately 36 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BGB-16673, Itraconazole and Phenytoin in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.