A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
- Registration Number
- NCT05844111
- Lead Sponsor
- BeiGene
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description [14C] radiolabeled BGB-11417 [14C]-BGB-11417 Participants will receive a single dose of \[14C\]-BGB-11417
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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)
Trial Locations
- Locations (1)
Ppd Development, Lp
🇺🇸Austin, Texas, United States