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

NCT07141511 | Completed Phase 1

• 1 other identifier: BG-71332-101
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

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

  Predose and up to 72 hours post dose

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

  Predose and up to 72 hours post dose

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

  Predose and up to 72 hours post dose

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

  Predose and up to 72 hours post dose

• Maximum observed plasma concentration (Cmax) of zanubrutinib

  Predose and up to 72 hours post dose

• Maximum observed plasma concentration (Cmax) of sonrotoclax

  Predose and up to 72 hours post dose

Secondary Outcomes (4)

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

  Up to 30 days after last dose, up to approximately 47 days

• Number of participants with laboratory abnormalities

  Up to 30 days after last dose, up to approximately 47 days

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

  Up to 30 days after last dose, up to approximately 47 days

• Number of participants with clinically significant vital signs measurements

  Up to 30 days after last dose, up to approximately 47 days

Study Arms (1)

BG-71332, Zanubrutinib + Sonrotoclax

EXPERIMENTAL

Participants will receive the following treatments in one of six sequences: one dose of BG-71332 with a high-fat meal, one dose of BG-71332 in a fasted state, and one dose of zanubrutinib and sonrotoclax administered together with a high-fat meal.

Drug: BG-71332; Drug: Zanubrutinib; Drug: Sonrotoclax

Interventions

BG-71332 DRUG

Administered orally

BG-71332, Zanubrutinib + Sonrotoclax

Zanubrutinib DRUG

Administered orally

Also known as: BGB-3111

BG-71332, Zanubrutinib + Sonrotoclax

Sonrotoclax DRUG

Administered orally

Also known as: BGB-11417

BG-71332, Zanubrutinib + Sonrotoclax

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (1)

Linear Early Phase

Joondalup, Western Australia, WA 6027, Australia

Location

MeSH Terms

Interventions

zanubrutinib

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: September 24, 2025
• Primary Completion: February 23, 2026
• Study Completion: February 23, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

AU (1)