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

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

Overview

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

• Drug Sonrotoclax Tablet for Oral Suspension
  Administered orally
• Drug Sonrotoclax Tablet
  Administered orally

Primary outcome measures

• 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]

Secondary outcome measures (7)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Open label

Primary purpose

Other

Study locations

Australia · 1 center

• Linear Early Phase — Joondalup

Identifiers

NCT: NCT07628881 · BGB-11417-110 · CT-2026-CTN-01536-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗