Healthy VolunteersPhase 1NCT05547399
Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults
A Phase 1 study testing Zanubrutinib in people with Healthy Volunteers, run by BeiGene at 1 site in United States.
Trial summary
Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet. 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
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 7 Dec 2022
- 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 signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- Female participants of non-childbearing potential only
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 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
- Use or intent to use prescription medications within 14 days prior to dosing or nonprescription medications/products/supplements within 7 days prior to check-in
- Use of tobacco or nicotine containing products within 3 months prior to check-in
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules and to Evaluate the Effects of Food on the Pharmacokinetics of the Zanubrutinib Tablet
Study to assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.
- 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 orally as a tablet or capsule
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Cohort | Experimental | Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences Receives: Drug: Zanubrutinib |
| High Dose Cohort | Experimental | Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences Receives: Drug: Zanubrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 7
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 7
Maximum observed plasma concentration (Cmax)
Measured: Predose and up to 48 hours postdose up to Day 7
Time of the maximum observed plasma concentration (Tmax)
Measured: Predose and up to 48 hours postdose up to Day 7
Apparent terminal elimination half-life (t1/2)
Measured: Predose and up to 48 hours postdose up to Day 7
Apparent volume of distribution (Vz/F)
Measured: Predose and up to 48 hours postdose up to Day 7
Rate of decrease of concentration in the terminal phase (λz)
Measured: Predose and up to 48 hours postdose up to Day 7
Apparent oral clearance (CL/F)
Measured: Predose and up to 48 hours postdose up to Day 7
Secondary outcomes (4)
Number of participants with adverse events (AEs)
Measured: Up to approximately 6 months
Number of participants with clinically significant laboratory values
Laboratory values are based on hematology, clinical chemistry, and urinalysis test results
Measured: Up to approximately 6 months
Number of participants with clinically significant electrocardiogram (ECG) results
Measured: Up to approximately 6 months
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 approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start7 Jun 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
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
- 43 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
- NCT05547399
- Sponsor's protocol ID
- BGB-3111-115
- Status last verified
- Oct 2024
- First submitted
- 16 Sep 2022
- 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, Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of a Zanubrutinib Tablet Compared to Zanubrutinib Capsules and to Evaluate the Effects of Food on the Pharmacokinetics of the Zanubrutinib Tablet
- ClinicalTrials.gov ID
- NCT05547399
- Acronym / sponsor ID
- BGB-3111-115
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 21 Sep 2022 (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 assess the relative bioavailability of zanubrutinib tablets compared to capsules and to evaluate the effects of food on the pharmacokinetics (PK) of the zanubrutinib tablet.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Cohort | Experimental | Drug: ZanubrutinibZanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences |
| High Dose Cohort | Experimental | Drug: ZanubrutinibZanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences |
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 signs measurements, and clinical laboratory evaluations as assessed by the investigator or designee
- Female participants of non-childbearing potential only
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) 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
- Use or intent to use prescription medications within 14 days prior to dosing or nonprescription medications/products/supplements within 7 days prior to check-in
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 orally as a tablet or capsule | Drug | High Dose Cohort, Low Dose Cohort |
Primary outcome
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 7
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 7
Maximum observed plasma concentration (Cmax)
Time frame: Predose and up to 48 hours postdose up to Day 7
Time of the maximum observed plasma concentration (Tmax)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent terminal elimination half-life (t1/2)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent volume of distribution (Vz/F)
Time frame: Predose and up to 48 hours postdose up to Day 7
Rate of decrease of concentration in the terminal phase (λz)
Time frame: Predose and up to 48 hours postdose up to Day 7
Apparent oral clearance (CL/F)
Time frame: Predose and up to 48 hours postdose up to Day 7
4 secondary outcomes
Number of participants with adverse events (AEs)
Time frame: Up to approximately 6 months
Number of participants with clinically significant laboratory values
Time frame: Up to approximately 6 months
Number of participants with clinically significant electrocardiogram (ECG) results
Time frame: Up to approximately 6 months
Number of participants with clinically significant vital sign measurements
Time frame: Up to approximately 6 months
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?
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 7). 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.