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

NCT07628881 | Not Yet Recruiting Phase 1

• 2 other identifiers: BGB-11417-110CT-2026-CTN-01536-1
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

BGB-11417; Sonrotoclax

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

Study Arms (1)

Sonrotoclax Tablet for Oral Suspension

EXPERIMENTAL

Participants will receive each of the following treatments as a single dose on 3 separate occasions with an 8-day washout in between: 1. oral dose of sonrotoclax tablet for oral suspension administered in the fed state with a high-fat meal. 2. oral dose of sonrotoclax tablet for oral suspension administered after fasting 3. oral dose of sonrotoclax tablet administered in the fed state with a high-fat meal.

Drug: Sonrotoclax Tablet for Oral Suspension; Drug: Sonrotoclax Tablet

Interventions

Sonrotoclax Tablet for Oral Suspension DRUG

Administered orally

Also known as: BGB-11417

Sonrotoclax Tablet for Oral Suspension

Sonrotoclax Tablet DRUG

Administered orally

Also known as: BGB-11417

Sonrotoclax Tablet for Oral Suspension

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• BeOne Medicines: lead

MeSH Terms

Interventions

Suspensions

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

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: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): June 18, 2026
• Primary Completion (Estimated): September 27, 2026
• Study Completion (Estimated): September 27, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

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