Clinical trial NCT05844111: A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
Official title: A Phase 1 Study To Investigate The Absorption, Metabolism, and Excretion of [14C]-BGB-11417 Following Single Oral Dose Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: BeiGene
Sponsor class: INDUSTRY
First posted: 2023-05-06
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Note: Other inclusion/exclusion criteria may apply

Primary outcomes:
measure: Area under the concentration curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t) of BGB-11417
timeFrame: From 0 to 168 hours after study drug administration
measure: Maximum concentration (Cmax) of BGB-11417 in Plasma
timeFrame: From 0 to 168 hours after study drug administration
measure: Time to Cmax (Tmax) of BGB-11417 in Plasma
timeFrame: From 0 to 168 hours after study drug administration
measure: Amount of BGB-11417-106 excreted (Ae) and Cumulative amount of BGB-11417-106 (Cum Ae) excreted in urine and feces
timeFrame: From 0 to 168 hours after study drug administration
measure: Percentage (%Fe) and cumulative percentage (Cum %Fe) of BGB-11417 or radioactive dose excreted in urine and feces
timeFrame: From 0 to 168 hours after study drug administration
Secondary outcomes:
measure: Number of participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From the day of screening until end of study (approximately 1 month)
Other outcomes:
Locations:
city: Austin
country: United States
facility: Ppd Development, Lp
state: Texas
Study officials:
References: