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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT05844111

Run by

BeiGene

People needed

6

Starts

2023-05-22

Expected to finish

2023-06-18

Last updated by the study team

2025-04-17

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

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
• 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

Where it is running

• Ppd Development, Lp — Austin, Texas, United States

Full record on ClinicalTrials.gov

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