Healthy VolunteersPhase 1NCT05767398
Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
A Phase 1 study testing Zanubrutinib in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult 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?
- Zanubrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to 28 Apr 2023
- 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
- Body mass index between 18.0 and 32.0 kg/m^2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)
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, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
- History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
- Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >upper limit of normal (ULN) range
- Positive hepatitis panel and/or positive human immunodeficiency virus test
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
- Conditions
- Healthy Volunteers
- Being tested
- Zanubrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZanubrutinibDrug
Also called BGB-3111, Brukinsa
Administered as a tablet or capsule
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. Receives: Drug: Zanubrutinib |
| Sequence 2 | Experimental | Zanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Measured: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: Predose and up to 48 hours postdose up to Day 10
Time of the maximum observed plasma concentration (Tmax)
Measured: Predose and up to 48 hours postdose up to Day 10
Apparent terminal elimination half-life (t1/2)
Measured: Predose and up to 48 hours postdose up to Day 10
Apparent volume of distribution (Vz/F)
Measured: Predose and up to 48 hours postdose up to Day 10
Rate of decrease of concentration in the terminal phase (λz)
Measured: Predose and up to 48 hours postdose up to Day 10
Apparent oral clearance (CL/F)
Measured: Predose and up to 48 hours postdose up to Day 10
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Measured: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant laboratory values
Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
Measured: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant electrocardiogram (ECG) results
Measured: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant vital sign measurements
Vital sign measurements include supine blood pressure, supine pulse rate, respiratory rate, and oral body temperature
Measured: Up to 30 days after last dose; up to approximately 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start7 Mar 2023
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT05767398
- Sponsor's protocol ID
- BGB-3111-114
- Status last verified
- Oct 2024
- First submitted
- 2 Mar 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-dose, Open-label, Randomized, Replicate Crossover Study in Healthy Adult Subjects to Assess the Bioequivalence of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules
- ClinicalTrials.gov ID
- NCT05767398
- Acronym / sponsor ID
- BGB-3111-114
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 14 Mar 2023 (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.
Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in healthy adult participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: ZanubrutinibZanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. |
| Sequence 2 | Experimental | Drug: ZanubrutinibZanubrutinib will be administered as a single dose of treatment (tablet) or reference (capsule) on separate occasions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index between 18.0 and 32.0 kg/m^2, inclusive
- In good health, determined by no clinically significant findings from medical history, 12-lead ECGs, vital sign measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- Female participants must be of non-childbearing potential (surgically sterile or postmenopausal)
Key exclusion criteria (7 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, COVID-19) within 4 weeks prior to the first dose of study drug, as determined by the investigator or designee
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator or designee
- History or presence of an abnormal ECG prior to the first dose of the study drug that, in the opinion of the investigator or designee, is clinically significant
- Abnormal liver function tests, as defined by aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin >upper limit of normal (ULN) range
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 |
|---|---|---|
| ZanubrutinibAlso: BGB-3111, BrukinsaAdministered as a tablet or capsule | Drug | Sequence 1, Sequence 2 |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)
Time frame: Predose and up to 48 hours postdose up to Day 10
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: Predose and up to 48 hours postdose up to Day 10
Time of the maximum observed plasma concentration (Tmax)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent terminal elimination half-life (t1/2)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent volume of distribution (Vz/F)
Time frame: Predose and up to 48 hours postdose up to Day 10
Rate of decrease of concentration in the terminal phase (λz)
Time frame: Predose and up to 48 hours postdose up to Day 10
Apparent oral clearance (CL/F)
Time frame: Predose and up to 48 hours postdose up to Day 10
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant laboratory values
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
Number of participants with clinically significant vital sign measurements
Time frame: Up to 30 days after last dose; up to approximately 7 weeks
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 26 Oct 2024.
- Individual participant dataSharing planned: Yes
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Screening Protocol
Pain
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 Zanubrutinib 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 7 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 26 Oct 2024. 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?
Maximum observed plasma concentration (Cmax) (time frame: Predose and up to 48 hours postdose up to Day 10). The study lists 8 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 26 Oct 2024.