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.
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.
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.
Surgically sterile (ie, through tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or hysterectomy).
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).
Crossover
Sonrotoclax Tablet for Oral Suspension
DrugAdministered orally
Sonrotoclax Tablet
DrugAdministered orally
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) for Sonrotoclax
Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t) for Sonrotoclax
Maximum Observed Plasma Concentration (Cmax) of Sonrotoclax
Time of the Maximum Observed Concentration (Tmax) for Sonrotoclax
Apparent Terminal Elimination Half-life (t1/2) for Sonrotoclax
Apparent Total Clearance (CL/F) for Sonrotoclax
Apparent Volume of Distribution (Vz/F) for Sonrotoclax
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