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

BeiGene

Status and phase: Completed; Phase 1

Conditions: Not Determined

Treatments: Drug: sonrotoclax; Drug: Itraconazole; Drug: Phenytoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06543043

QSC302214 (Other Identifier)

BGB-11417-107

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Part A: Phenytoin + Sonrotoclax

Experimental group

Description:

Part A is designed to determine the effect of multiple doses of phenytoin on sonrotoclax in healthy participants.

Treatment:

Drug: Phenytoin

Drug: sonrotoclax

Part B: Itraconazole + Sonrotoclax

Experimental group

Description:

Part B is designed to determine the effect of multiple doses of itraconazole on sonrotoclax in healthy participants.

Treatment:

Drug: Itraconazole

Drug: sonrotoclax