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

Sponsor
BeOne Medicines
Study ID
NCT07141511
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • BG-71332 — DRUG
    Administered orally
  • Zanubrutinib — DRUG
    Administered orally
  • Sonrotoclax — DRUG
    Administered orally

Study Details

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.

Key Dates

Start date
Sep 24, 2025
Status verified
Apr 2026
Primary completion
Feb 23, 2026
Completion
Feb 23, 2026

Study Design

Enrollment
24 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: BG-71332, Zanubrutinib + Sonrotoclax
    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.

Primary Outcome Measure

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 ]

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