A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults

A Phase 1, Single-dose, Open-label, Randomized, Crossover Study in Healthy Adult Participants to Evaluate Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax

The purpose of this study is to evaluate whether blood levels of sonrotoclax after administration of a tablet for oral suspension are similar to those observed with the current sonrotoclax tablet. In addition, this study evaluates the effect of food on the absorption of sonrotoclax after administration of the tablet for oral suspension and the resulting blood levels of sonrotoclax.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Sonrotoclax Tablet for Oral Suspension; Drug: Sonrotoclax Tablet

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1-877-828-5568; Email: clinicaltrials@beonemed.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participants must sign the informed consent form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
• Participants who are overtly healthy as determined by no clinically significant findings from medical history, clinical laboratory assessments, vital sign measurements, 12-lead electrocardiogram (ECG), and physical examination at screening and check-in as determined by the Investigator, with additional requirements as follows:
• Body mass index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
• An absolute B-cell count of > 150 cells per microliter (cells/μL). If the B-cell count is < 150 cells/μL, the assessment will be repeated. If the repeat value is > 150 cells/μL, the participant may be enrolled after consultation with the medical monitor.
• Female participants of non-childbearing potential who meet any of the following criteria:
• Surgically sterile (ie, through tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy).
• Postmenopausal, defined as: with no spontaneous menses for ≥ 12 months in the absence of prior chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle stimulating hormone (FSH) in the postmenopausal range.
• 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 last dose of study treatment

Exclusion Criteria:

• Significant medical history or conditions: 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.
• Investigator discretion: participants who, in the opinion of the Investigator or designee, should not participate in the study for any other reason.
• Hypersensitivity or allergies: history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the Investigator or designee.
• Stomach or intestinal surgery: history of gastrointestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed).
• Surgery or trauma: major surgical procedure or significant traumatic injury within 3 months prior to check-in or anticipation of the need for major surgery during the study.
• Medications affecting drug metabolism: use or intent to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St.John's wort, moderate/strong CYP3A inhibitors or inducers, or P-glycoprotein (P-gp)/breast cancer resistance protein (BCRP) inhibitors, within 30 days prior to dosing
• Infections: evidence of any infections (bacterial, viral, fungal, parasitic) within 4 weeks prior to the first dose of study treatment, as determined by the Investigator (or designee).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Sonrotoclax Tablet for Oral Suspension; Participants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between: oral dose of sonrotoclax tablet for oral suspension administered in the fed state with a high-fat meal.; oral dose of sonrotoclax tablet for oral suspension administered after fasting; oral dose of sonrotoclax tablet administered in the fed state with a high-fat meal.

Drug: Sonrotoclax Tablet for Oral Suspension; Administered orally; Other Names: BGB-11417; Drug: Sonrotoclax Tablet; Administered orally; Other Names: BGB-11417

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax	Approximately 20 days
Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax	Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax	Approximately 20 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax		Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax		Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax		Approximately 20 days
Apparent Volume of Distribution (Vz/F) for Sonrotoclax		Approximately 20 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)		Up to approximately 47 days
Number of Participants with Abnormal Clinically Significant Electrocardiogram (ECG) Values	Clinically significant ECG values include a prolonged QT interval, presence of atrial fibrillation or other significant arrhythmia.	Up to approximately 47 days
Number of Participants with Clinically Significant Vital Signs Measurements	Vital signs include pulse rate, body temperature, and blood pressure.	Up to approximately 47 days

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: BGB-11417; Sonrotoclax
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Complex Mixtures; Colloids; Suspensions
• Other Study ID Numbers: BGB-11417-110; CT-2026-CTN-01536-1 (Other Identifier: Australia Therapeutic Goods Administration (TGA):)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No