A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Sonrotoclax (BGB-11417) in Healthy Subjects

This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.

Inclusion Criteria:

• Able to understand and sign a written informed consent
• Able and willing to comply with all study requirements
• Healthy males or healthy females of non-childbearing potential
• Agrees to use an adequate method of contraception
• Body mass index (BMI) of 18.0 to 32.0 kg/m^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Exclusion Criteria:

• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
• Prior treatment with sonrotoclax
• Evidence of renal impairment at screening
• Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
• Current smokers and those who have smoked within the last 12 months
• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
• History of any drug or alcohol abuse in the past 2 years
• Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
• History of clinically significant disorders as judged by the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.