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BGB-58067

Phase 1

Healthy Volunteers | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: May 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07590102A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy ParticipantsPHASE1 NOT YET_RECRUITING 30Jun 1, 2026Sep 30, 2026May 15, 2026 -
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Study Endpoints
Primary Endpoints
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Secondary Endpoints
Part A and Part B: Number of Participants with Adverse Events (AEs)
Up to approximately 30 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: BGB-58067 + Phenytoin (CYP3A Inducer)EXPERIMENTALParticipants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.
Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)EXPERIMENTALParticipants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.
Interventions
NameTypeDescription
BGB-58067DRUGAdministered orally
PhenytoinDRUGAdministered orally
ItraconazoleDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol * Participants must be willing and able to comply with all study re...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07590102primaryCompletionDate: changed
LOWMay 24, 2026NCT07590102studyFirstPostDate: changed
LOWMay 21, 2026NCT07590102NEW_TRIAL: changed
LOWMay 21, 2026NCT07590102NEW_TRIAL: changed