Recent Updates
Recently added Catalysts

-BGB-11417

Phase 1

Healthy Volunteers | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Apr 17, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05844111A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417PHASE1 COMPLETED 6 — — May 22, 2023Jun 18, 2023Apr 17, 20251 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
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 Endpoints
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)
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
[14C] radiolabeled BGB-11417EXPERIMENTALParticipants will receive a single dose of \[14C\]-BGB-11417
Interventions
NameTypeDescription
[14C]-BGB-11417DRUGA single oral dose of liquid formulation
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexMALE
Healthy VolunteersYes
Study Sites1

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 screenin...

Countries:United States
Unlock Eligibility Criteria