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

BeiGene30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Not Determined

Interventions

PhenytoinDRUG

Administered orally.

ItraconazoleDRUG

Administered orally.

sonrotoclaxDRUG

Administered orally.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Quotient Sciences

Miami, Florida, United States

Outcomes

Primary Outcomes

Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax