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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: [14C]-BGB-11417


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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) |