Healthy Volunteers
Conditions
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.
Interventions
DRUG[14C]-BGB-11417
A single oral dose of liquid formulation
Sponsors
BeiGene
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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) |
Countries
United States
Outcome results
None listed