Not yet recruitingNCT07855991Updated Oct 2, 2026

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

A Phase 1 interventional study of Sonrotoclax in Hepatic Impairment and Healthy Adult Participants, sponsored by BeOne Medicines. Not yet recruiting. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by BeOne Medicines · Phase 1, Interventional, and Other

Updated Oct 2, 2026Newly registeredGo to Updates ↓

Phase: Phase 1
Study type: Interventional
Enrollment: 12
Allocation: Non-randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 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 studied

Hepatic Impairment
Healthy Adult Participants

Keywords

sonrotoclax
Pharmacokinetics
BCL2i

In context

Lead sponsor

BeOne Medicines is the lead sponsor of 61 studies on the registry; 42 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

General Inclusion Criteria:

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

Inclusion Criteria for Severe Hepatic Impairment Group:

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

Inclusion Criteria for Normal Hepatic Function Group:

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
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

Exclusion Criteria for Severe Hepatic Impairment Group:

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

Exclusion Criteria for Normal Hepatic Function Group:

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.

Study design

Phase: Phase 1
Primary purpose: Other
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 12 participants (estimated)

Study arms

Experimental
Group 1: Severe Hepatic Impairment
Participants with severe hepatic impairment will receive a single dose of sonrotoclax on Day 1.
Drug: Sonrotoclax
Experimental
Group 2: Normal Hepatic Function
Participants with normal hepatic function will receive a single dose of sonrotoclax on Day 1.
Drug: Sonrotoclax

Interventions

DrugSonrotoclax
Single dose administered orally.
Also known as: BGB-11417, BEQALZI

What researchers measure

Primary outcomes

Area under the plasma concentration-time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of Sonrotoclax
Time frame: Days 1-3
AUC from time 0 extrapolated to infinity (AUC0-inf) of Sonrotoclax
Time frame: Days 1-3
Maximum observed plasma concentration (Cmax) of Sonrotoclax
Time frame: Days 1-3
Time to reach maximum observed plasma concentration (Tmax) of Sonrotoclax
Time frame: Days 1-3
Apparent terminal elimination half-life (t1/2) of Sonrotoclax
Time frame: Days 1-3
Apparent oral clearance (CL/F) of Sonrotoclax
Time frame: Days 1-3
Apparent volume of distribution (Vz/F) of Sonrotoclax
Time frame: Days 1-3
Fraction unbound (Fu) of Sonrotoclax
Time frame: Day 1

Secondary outcomes

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.
Time frame: 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.
Time frame: Approximately 3 days
Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
Time frame: 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.
Time frame: Approximately 3 days

Study locations

No study locations are listed for this record.

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Oct 2, 2026

Show all 1 update

Oct 2, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07855991
Lead sponsor: BeOne Medicines
Responsible party: Sponsor
First posted: Oct 2, 2026
Start date: Oct 15, 2026 (estimated)
Primary completion: Feb 8, 2027 (estimated)
Completion: Feb 8, 2027 (estimated)
Last update: Oct 2, 2026

Study contacts

Study Director

Contact

clinicaltrials@beonemed.com

1.877.828.5568

Study Director

study director · BeOne Medicines

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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