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

Sponsor
BeiGene (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05844111
Collaborator
(none)
6
Enrollment
1
Arm
1
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: [14C] radiolabeled BGB-11417

Participants will receive a single dose of [14C]-BGB-11417

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

Outcome Measures

Primary Outcome Measures

  1. 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]

  2. Maximum concentration (Cmax) of BGB-11417 in Plasma [From 0 to 168 hours after study drug administration]

  3. Time to Cmax (Tmax) of BGB-11417 in Plasma [From 0 to 168 hours after study drug administration]

  4. 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]

  5. 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

  1. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts 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/exclusion criteria may apply

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • BeiGene

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
BeiGene
ClinicalTrials.gov Identifier:
NCT05844111
Other Study ID Numbers:
  • BGB-11417-106
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 6, 2023