Healthy volunteers to test new version of cancer drug
NCT ID NCT07628881
First seen Jun 26, 2026 · Last updated Jul 10, 2026 · Updated 3 times
Summary
This early-stage trial will test a new tablet form of sonrotoclax that can be mixed with water and swallowed. Researchers want to see if the body absorbs it the same way as the current tablet, and whether taking it with food changes absorption. Twelve healthy adults will each receive single doses under different conditions to compare blood levels.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- sonrotoclax (BGB-11417)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Linear Early Phase
RECRUITINGJoondalup, Western Australia, WA 6027, Australia
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