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BMS-986165-01

Phase 1

Lupus | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jan 6, 2021

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04065932A Study to Determine the Pharmacokinetic Profile of BMS-986165 TabletsPHASE1 COMPLETED 33 — — Aug 22, 2019Dec 10, 2019Jan 6, 20211 United Kingdom
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax) for BMS-986165
Day 1 of treatment
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration- AUC(0-T) for BMS- 986165
Day 1 of treatment
Area under the plasma concentration-time curve from time zero extrapolated to infinite time- AUC(INF) for BMS-986165
Day 1 of treatment
Secondary Endpoints
Time to maximum observed plasma concentration-(Tmax) for BMS -986165
Day 1 of treatment
Apparent plasma elimination half-life- (T-HALF) for BMS-986165
Day 1 of treatment
Area under the concentration-time curve from time zero to 24 hours post- (AUC 0-24) for BMS-986165
Day 1 of treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-985165-01 prototype formulation 1EXPERIMENTAL -
BMS-986165 TabletEXPERIMENTAL -
BMS-985165-01 prototype formulation 2EXPERIMENTAL -
BMS-985165-01 prototype formulation 3EXPERIMENTAL -
BMS-985165-01 prototype formulation 3 or 4EXPERIMENTAL -
BMS-985165-01 prototype formulation 3, 4 or 5EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986165-01DRUGParticipants will receive BMS- 986165 -01 in prototype formulation
BMS-986165 TabletDRUGParticipants will receive BMS-986165 in tablet form.
FamotidineDRUGParticipants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Patients must be willing and able to complete all study-specific procedures and visits * Healthy patients, as determined by no clinically significant deviati...

Countries:United Kingdom
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Competitive Landscape -Lupus Nephritis 26 trials
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