Healthy VolunteersPhase 1NCT07628881
A Study to Investigate the Relative Bioavailability and Food Effect of Tablet for Oral Suspension of Sonrotoclax in Healthy Adults
A Phase 1 study testing Sonrotoclax Tablet for Oral Suspension and Sonrotoclax Tablet in people with Healthy Volunteers, run by BeOne Medicines at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Sonrotoclax Tablet for Oral Suspension and Sonrotoclax Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 17 Jun 2026to 26 Sep 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- Sonrotoclax Tablet for Oral Suspension, Sonrotoclax Tablet
- Keywords
- BGB-11417, Sonrotoclax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonrotoclax Tablet for Oral SuspensionDrug
Also called BGB-11417
Administered orally
Sonrotoclax TabletDrug
Also called BGB-11417
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Sonrotoclax Tablet for Oral Suspension; Drug: Sonrotoclax Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Measured: 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
Measured: Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Measured: Approximately 20 days
Secondary outcomes (7)
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Measured: Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Measured: Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax
Measured: Approximately 20 days
Apparent Volume of Distribution (Vz/F) for Sonrotoclax
Measured: Approximately 20 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: 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.
Measured: Up to approximately 47 days
Number of Participants with Clinically Significant Vital Signs Measurements
Vital signs include pulse rate, body temperature, and blood pressure.
Measured: Up to approximately 47 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start17 Jun 2026
- Primary completion26 Sep 2026
- Study completion26 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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
- NCT07628881
- Sponsor's protocol ID
- BGB-11417-110
- Other IDs
- CT-2026-CTN-01536-1
- Status last verified
- Oct 2026
- First submitted
- 22 May 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07628881
- Acronym / sponsor ID
- BGB-11417-110
- Conditions
- Healthy Volunteers
- Keywords
- BGB-11417, Sonrotoclax
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- BeOne MedicinesIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- 26 Sep 2026 (actual)
- Study completion
- 26 Sep 2026 (actual)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonrotoclax Tablet for Oral Suspension | Experimental | Drug: Sonrotoclax Tablet for Oral Suspension, Drug: Sonrotoclax TabletParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonrotoclax Tablet for Oral SuspensionAlso: BGB-11417Administered orally | Drug | Sonrotoclax Tablet for Oral Suspension |
| Sonrotoclax TabletAlso: BGB-11417Administered orally | Drug | Sonrotoclax Tablet for Oral Suspension |
Primary outcome
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Time frame: 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
Time frame: Approximately 20 days
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Time frame: Approximately 20 days
7 secondary outcomes
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Total Clearance (CL/F) for Sonrotoclax
Time frame: Approximately 20 days
Apparent Volume of Distribution (Vz/F) for Sonrotoclax
Time frame: Approximately 20 days
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to approximately 47 days
Number of Participants with Abnormal Clinically Significant Electrocardiogram (ECG) Values
Time frame: Up to approximately 47 days
Number of Participants with Clinically Significant Vital Signs Measurements
Time frame: Up to approximately 47 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeOne Medicines
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sonrotoclax Tablet for Oral Suspension and Sonrotoclax Tablet in people with Healthy Volunteers, run by BeOne Medicines at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax (time frame: Approximately 20 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.