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BGB-3111 and Drug Cocktail

Phase 1

Healthy Subjects | Small molecule | Other |BeOne Medicines Ltd.|Last Updated: Nov 4, 2019

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03561298A Pharmacokinetic Study to Assess Drug-drug Interaction Between Zanubrutinib and a Cocktail of Substrates in Healthy SubjectsPHASE1 COMPLETED 18Jun 7, 2018Jul 2, 2018Nov 4, 20191 United States
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Study Endpoints
Primary Endpoints
PK parameters of probe drugs (warfarin, midazolam, digoxin, rosuvastatin, and omeprazole) derived from the plasma concentration time profile before and after oral administration of zanubrutinib
Days 1-20

AUC from time 0 to the last quantifiable concentration (AUC0-t)

Secondary Endpoints
Number of participants with adverse events as a measure of safety and tolerability.
up to 26 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Arm: BGB-3111 + Drug CocktailEXPERIMENTALBGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
Interventions
NameTypeDescription
BGB-3111 and Drug CocktailDRUGBGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
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Eligibility Criteria
Age Range18 Years — 60 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: All Groups * Male subjects in good health as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at screening. * Subjects must have a body mass index (BMI) between 18 and 32 kg/m2. * Male subjects must agree to a highly effective metho...

Countries:United States
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