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CompletedNCT05547399Updated Oct 26, 2024

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

A Phase 1 interventional study of Zanubrutinib 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 2024-10-26.

Sponsored by BeiGene · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Dec 2022, 3 years 10 months ago, and no results have been posted to the registry.
  • Registered 3 months after the study started (first participant enrolled Jun 2022, registered Sep 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteers
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

  • 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

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 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

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Low Dose Cohort

    Zanubrutinib will be administered as a single low dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences

    Drug: Zanubrutinib

  • Experimental
    High Dose Cohort

    Zanubrutinib will be administered as a single high dose of treatment (tablet) or reference (capsule) on separate occasions across several treatment sequences

    Drug: Zanubrutinib

Interventions

  • DrugZanubrutinib

    Administered orally as a tablet or capsule

    Also known as: BGB-3111, Brukinsa

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Predose and up to 48 hours postdose up to Day 7

  4. Time of the maximum observed plasma concentration (Tmax)

    Time frame: Predose and up to 48 hours postdose up to Day 7

  5. Apparent terminal elimination half-life (t1/2)

    Time frame: Predose and up to 48 hours postdose up to Day 7

  6. Apparent volume of distribution (Vz/F)

    Time frame: Predose and up to 48 hours postdose up to Day 7

  7. Rate of decrease of concentration in the terminal phase (λz)

    Time frame: Predose and up to 48 hours postdose up to Day 7

  8. Apparent oral clearance (CL/F)

    Time frame: Predose and up to 48 hours postdose up to Day 7

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to approximately 6 months

  2. Number of participants with clinically significant laboratory values

    Laboratory values are based on hematology, clinical chemistry, and urinalysis test results

    Time frame: Up to approximately 6 months

  3. Number of participants with clinically significant electrocardiogram (ECG) results

    Time frame: Up to approximately 6 months

  4. 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

    Time frame: Up to approximately 6 months

07

Study locations

1 site
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
08

References and documents

Individual participant data

Plan to share: Yes

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 Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05547399
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
Sep 21, 2022
Start date
Jun 7, 2022
Primary completion
Dec 7, 2022
Completion
Dec 7, 2022
Last update
Oct 26, 2024

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 Oct 2024. You cannot join it, but the record below documents what was studied.

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