A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417

NCT ID: NCT05844111

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2023-06-18

Brief Summary

The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma, fecal and urinary elimination of total radioactivity.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C] radiolabeled BGB-11417

Participants will receive a single dose of \[14C\]-BGB-11417

Group Type: EXPERIMENTAL

[14C]-BGB-11417

Intervention Type: DRUG

A single oral dose of liquid formulation

Interventions

[14C]-BGB-11417

A single oral dose of liquid formulation

Intervention Type: DRUG

Other Intervention Names

Sonrotoclax

Eligibility Criteria

Inclusion Criteria

• The participant is judged by the investigator to be in good general health, 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
• The participant has a body mass index from 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive, at screening
• The participant has normal hepatic function (Note: Participants with Gilbert's syndrome should not be included)
• Participants must be willing to follow contraceptive practices, as applicable, from check-in until 90 days following study drug administration
• Participants must be willing to refrain from donating sperm from check-in until 90 days following study drug administration

Exclusion Criteria

• The participant has an absolute B-lymphocyte count of <200 cells/μL
• The participant has a medical history of any issues affecting swallowing, absorption, or metabolism, as judged by the investigator
• The participant has a medical history of any problems affecting venous access or bowel/bladder function
• The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening
• The participant is a smoker or has used nicotine or nicotine-containing products within 6 months before the first dose of study drug
• The subject has creatinine clearance of <90 mL/min, calculated with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• The participant has used any prescription or over-the-counter medications (except acetaminophen [up to 2 grams per day]), including herbal or nutritional supplements, within 14 days before the first dose of study drug
• The participant received any treatment with a moderate CYP3A4 inhibitor or strong CYP3A4 inducer within 14 days (or 5 half-lives, whichever is longer) before the first dose of study drug or during the study
• The participant has consumed grapefruit or grapefruit juice, Seville orange or Seville-orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug or during the study
• The participant has a history of alcohol abuse or drug addiction or psychiatric disorders including major depression disorder within the last year or excessive alcohol consumption (regular alcohol intake >21 units per week) (1 unit is equal to approximately one-half pint [200 mL] of beer, 1 small glass [100 mL] of wine, or 1 measure [25 mL] of spirits
• The participant has a positive test result for drugs of abuse, alcohol, or cotinine (indicating active current smoking) at screening or before the first dose of study drug.
• The participant is involved in strenuous activity or contact sports within 24 hours before the first dose of study drug or during the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

BeiGene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ppd Development, Lp

Austin, Texas, United States

Countries

United States

Other Identifiers

BGB-11417-106

Identifier Type: -

Identifier Source: org_study_id