A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment

NCT07855991 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: BGB-11417-112
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this study is to understand how the body processes sonrotoclax in adults with serious liver problems compared to adults with normal liver function.

Conditions

Hepatic Impairment; Healthy Adult Participants

Keywords

sonrotoclax; Pharmacokinetics; BCL2i

Outcome Measures

Primary Outcomes (8)

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

  Days 1-3

• AUC from time 0 extrapolated to infinity (AUC0-inf) of Sonrotoclax

  Days 1-3

• Maximum observed plasma concentration (Cmax) of Sonrotoclax

  Days 1-3

• Time to reach maximum observed plasma concentration (Tmax) of Sonrotoclax

  Days 1-3

• Apparent terminal elimination half-life (t1/2) of Sonrotoclax

  Days 1-3

• Apparent oral clearance (CL/F) of Sonrotoclax

  Days 1-3

• Apparent volume of distribution (Vz/F) of Sonrotoclax

  Days 1-3

• Fraction unbound (Fu) of Sonrotoclax

  Day 1

Secondary Outcomes (4)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Approximately 10 days

• Number of Participants with Laboratory Abnormalities

  Approximately 3 days

• Number of Participants with Clinically Significant Vital Signs Measurements

  Approximately 3 days

• Number of Participants with Clinically Significant Physical Examination Findings

  Approximately 3 days

Study Arms (2)

Group 1: Severe Hepatic Impairment

EXPERIMENTAL

Participants with severe hepatic impairment will receive a single dose of sonrotoclax on Day 1.

Drug: Sonrotoclax

Group 2: Normal Hepatic Function

EXPERIMENTAL

Participants with normal hepatic function will receive a single dose of sonrotoclax on Day 1.

Drug: Sonrotoclax

Interventions

Sonrotoclax DRUG

Single dose administered orally.

Also known as: BGB-11417, BEQALZI

Group 1: Severe Hepatic Impairment; Group 2: Normal Hepatic Function

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) between 18.0 and 42.0 kg/m\^2, inclusive
• Generally stable health (except for hepatic impairment in hepatically impaired participants) as determined by the Investigator based on medical evaluation at Screening and Check-in, with no clinically significant findings that would interfere with study participation
• Female participants of non-childbearing potential who meet any of the following criteria: surgically sterile or postmenopausal
• Male participants are eligible if vasectomized or if they agree to the use of barrier contraception with other highly effective methods if sexually active with women of childbearing potential, during study treatment and for at least 7 days after the dose of study drug
• Severe hepatic dysfunction per National Cancer Institute-Organ Dysfunction Working Group (NCI-ODWG) criteria (serum total bilirubin \> 3 × upper limit of normal \[ULN\], any aspartate aminotransferase \[AST\])
• Clinically stable hepatic disease, in the opinion of the investigator, with no clinically significant worsening of hepatic function within 4 weeks prior to dosing
• Normal hepatic function, including total bilirubin ≤ ULN and AST ≤ ULN
• Absolute B-cell count of \> 150 cells/μL

You may not qualify if:

• Any clinically significant disease or condition that, in the opinion of the Investigator, would interfere with study participation, safety, or evaluation of study results
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator
• Evidence of any infections (bacterial, viral, fungal, parasitic) within 2-4 weeks prior to the first dose of study drug, as determined by the investigator (or designee)
• Positive urine drug screen or alcohol urine/breath test/blood results at screening or check-in
• History of alcoholism or drug/chemical abuse within the last 2 years
• Acute hepatic disease or rapidly deteriorating hepatic function
• History of liver transplantation
• Previously diagnosed hepatocellular carcinoma, or history of cholestatic liver disease or biliary sepsis within the past 2 years
• Any known or suspected hepatic disease
• Clinically significant abnormalities in liver function tests at Screening
• Require ongoing use of prescription or nonprescription medications, including herbal supplements (unless the medication is not expected to interfere with the pharmacokinetics, safety, or tolerability of the study drug)

Sponsors & Collaborators

• BeOne Medicines: lead

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

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

Study Record Dates

• First Submitted: September 29, 2026
• First Posted: October 2, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): February 8, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

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