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Completed

NCT Number: NCT07141511

A Study to Investigate the Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332) in Healthy Adults

The purpose of this study is to evaluate the relative bioavailability of a fixed-dose combination tablet containing zanubrutinib and sonrotoclax (BG-71332) compared to a zanubrutinib capsule and sonrotoclax tablet administered simultaneously and the effect of food on how the body processes the fixed-dose combination tablet.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Early Phase

Joondalup, Western Australia, WA 6027, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • An absolute B-cell count of >200 cells/μL.
  • Female participants must be of non-childbearing potential (surgically sterile or postmenopausal).

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).

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BG-71332

Drug

Administered orally

Zanubrutinib

Drug

Administered orally

Other names: BGB-3111

Sonrotoclax

Drug

Administered orally

Other names: BGB-11417

Primary outcomes

  1. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for zanubrutinib

    Time frame: Predose and up to 72 hours post dose

  2. Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) for sonrotoclax

    Time frame: Predose and up to 72 hours post dose

  3. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for zanubrutinib

    Time frame: Predose and up to 72 hours post dose

  4. Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (AUC0-t) for sonrotoclax

    Time frame: Predose and up to 72 hours post dose

  5. Maximum observed plasma concentration (Cmax) of zanubrutinib

    Time frame: Predose and up to 72 hours post dose

  6. Maximum observed plasma concentration (Cmax) of sonrotoclax

    Time frame: Predose and up to 72 hours post dose

Secondary outcomes

  1. Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to 30 days after last dose, up to approximately 47 days

  2. Number of participants with laboratory abnormalities

    Time frame: Up to 30 days after last dose, up to approximately 47 days

    Laboratory parameters include hematology, clinical chemistry, and urinalysis test results

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

    Time frame: Up to 30 days after last dose, up to approximately 47 days

  4. Number of participants with clinically significant vital signs measurements

    Time frame: Up to 30 days after last dose, up to approximately 47 days

Sponsors and collaborators

Lead sponsor

BeOne Medicines

Industry

Registry information

Official study title

A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of a Fixed-Dose Combination Tablet Containing Zanubrutinib and Sonrotoclax (BG-71332)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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