Clinical trial NCT06543043: A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Not Determined
Keywords: sonrotoclax
BGB-11417
healthy volunteers
phenytoin
itraconazole
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2024-08-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Apparent oral clearance (CL/F) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
measure: Parts A and B: Apparent volume of distribution (Vz/F) of sonrotoclax
timeFrame: Approximately 21 days for Part A and 11 days for Part B
Secondary outcomes:
measure: Parts A and B: Number of Participants with Adverse Events (AEs)
timeFrame: From time of providing written informed consent until up to 30 days after the final dose of study treatment for each part of the study; approximately 8 weeks for Part A and approximately 7 weeks for Part B
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences
state: Florida
Study officials:
affiliation: BeiGene
name: Study Director
role: STUDY_DIRECTOR
References: