Healthy Volunteers
Conditions
Keywords
BGB-11417, Sonrotoclax
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.
Interventions
DRUGSonrotoclax Tablet for Oral Suspension
Administered orally
DRUGSonrotoclax Tablet
Administered orally
Sponsors
BeOne Medicines
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to approximately 47 days | Clinically significant ECG values include a prolonged QT interval, presence of atrial fibrillation or other significant arrhythmia. |
| Number of Participants with Clinically Significant Vital Signs Measurements | Up to approximately 47 days | Vital signs include pulse rate, body temperature, and blood pressure. |
Countries
Australia
Contacts
CONTACTStudy Director
STUDY_DIRECTORStudy Director
BeOne Medicines
Outcome results
None listed