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

A Phase 1 Study To Investigate The Absorption, Metabolism, and Excretion of [14C]-BGB-11417 Following Single Oral Dose Administration in Healthy Male Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-BGB-11417

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78744-1645
      • PPD Development, LP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Note: Other inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C] radiolabeled BGB-11417; Participants will receive a single dose of [14C]-BGB-11417	Drug: [14C]-BGB-11417; A single oral dose of liquid formulation; Other Names: Sonrotoclax

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417	From 0 to 168 hours after study drug administration
Maximum concentration (Cmax) of BGB-11417 in Plasma	From 0 to 168 hours after study drug administration
Time to Cmax (Tmax) of BGB-11417 in Plasma	From 0 to 168 hours after study drug administration
Amount of BGB-11417-106 excreted (Ae) and Cumulative amount of BGB-11417-106 (Cum Ae) excreted in urine and feces	From 0 to 168 hours after study drug administration
Percentage (%Fe) and cumulative percentage (Cum %Fe) of BGB-11417 or radioactive dose excreted in urine and feces	From 0 to 168 hours after study drug administration

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	From the day of screening until end of study (approximately 1 month)

Collaborators and Investigators

• Sponsor: BeiGene

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Actual): June 18, 2023
• Study Completion (Actual): June 18, 2023

Study Registration Dates

• First Submitted: April 25, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: BGB-11417-106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No