Hepatic ImpairmentPhase 1NCT07855991
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
A Phase 1 study testing Sonrotoclax in people with Hepatic Impairment and Healthy Adult Participants, run by BeOne Medicines.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Adult Participants
- What is being tested?
- Sonrotoclax
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to 8 Feb 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- General Exclusion Criteria:
- Any clinically significant disease or condition that, in the opinion of the Investigator, would interfere with study participation, safety, or evaluation of study results
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- 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
Who cannot join
- 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)
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Sonrotoclax in Participants With Severe Hepatic Impairment
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.
Read the detailed description
Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Bcl-2 helps certain blood cancer cells live and grow. By blocking Bcl-2, sonrotoclax may slow or stop cancer cell growth and help them die.
The purpose of this study is to look at the safety and blood levels of sonrotoclax in adults with serious liver problems. Results from this study will help researchers understand if dose changes are needed for adults with liver problems.
Participants will take one dose of sonrotoclax by mouth with food and remain in the clinic for about 3 days of monitoring. This study is an open-label study, meaning that both participants and study doctors will know what study drug/treatment is given.
The study will enroll approximately 12 adults in the United States (6 adults with serious liver problems and 6 adults with normal liver function).
The overall time to participate in this study is approximately 4 weeks. Participants will make regular visits to the clinic for health checks, blood tests, sonrotoclax administration and monitoring, and follow-up.
- Conditions
- Hepatic Impairment, Healthy Adult Participants
- Being tested
- Sonrotoclax
- Keywords
- sonrotoclax, Pharmacokinetics, BCL2i
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonrotoclaxDrug
Also called BGB-11417, BEQALZI
Single dose administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Severe Hepatic Impairment | Experimental | Participants with severe hepatic impairment will receive a single dose of sonrotoclax on Day 1. Receives: Drug: Sonrotoclax |
| Group 2: Normal Hepatic Function | Experimental | Participants with normal hepatic function will receive a single dose of sonrotoclax on Day 1. Receives: Drug: Sonrotoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of Sonrotoclax
Measured: Days 1-3
AUC from time 0 extrapolated to infinity (AUC0-inf) of Sonrotoclax
Measured: Days 1-3
Maximum observed plasma concentration (Cmax) of Sonrotoclax
Measured: Days 1-3
Time to reach maximum observed plasma concentration (Tmax) of Sonrotoclax
Measured: Days 1-3
Apparent terminal elimination half-life (t1/2) of Sonrotoclax
Measured: Days 1-3
Apparent oral clearance (CL/F) of Sonrotoclax
Measured: Days 1-3
Apparent volume of distribution (Vz/F) of Sonrotoclax
Measured: Days 1-3
Fraction unbound (Fu) of Sonrotoclax
Measured: Day 1
Secondary outcomes (4)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with TEAEs and SAEs, including adverse events with onset or increase in severity level on or after single dose administration.
Measured: Approximately 10 days
Number of Participants with Laboratory Abnormalities
Number of participants with laboratory abnormalities, based on hematology, clinical chemistry, and urinalysis test results. Clinical laboratory values will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 for selected laboratory analytes.
Measured: Approximately 3 days
Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
Measured: Approximately 3 days
Number of Participants with Clinically Significant Physical Examination Findings
Number of participants with clinically significant physical examination findings, including new or worsened clinically significant abnormalities.
Measured: Approximately 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion8 Feb 2027 (estimated)
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855991
- Sponsor's protocol ID
- BGB-11417-112
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.