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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05844111
• Other study ID #: BGB-11417-106
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2023
• Est. completion date: June 18, 2023

Study information

• Verified date: July 2023
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 18, 2023
• Est. primary completion date: June 18, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]-BGB-11417
A single oral dose of liquid formulation

Locations

Country	Name	City	State
United States	Ppd Development, Lp	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum concentration (Cmax) of BGB-11417 in Plasma		From 0 to 168 hours after study drug administration
Primary	Time to Cmax (Tmax) of BGB-11417 in Plasma		From 0 to 168 hours after study drug administration
Primary	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
Primary	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	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)