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

BeiGene

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: [14C]-BGB-11417

Study type

Interventional

Funder types

Industry

Identifiers

NCT05844111

BGB-11417-106

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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