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

NCT05844111 | Completed Phase 1 FDA Drug

• 1 other identifier: BGB-11417-106
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (1)

• 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)

Study Arms (1)

[14C] radiolabeled BGB-11417

EXPERIMENTAL

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

Drug: [14C]-BGB-11417

Interventions

[14C]-BGB-11417 DRUG

A single oral dose of liquid formulation

Also known as: Sonrotoclax

[14C] radiolabeled BGB-11417

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BeiGene: lead

Study Sites (1)

Ppd Development, Lp

Austin, Texas, 78744-1645, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: May 22, 2023
• Primary Completion: June 18, 2023
• Study Completion: June 18, 2023
• Last Updated: April 17, 2025

Record last verified: 2025-04

Locations

US (1)