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Recently added Catalysts

-BMS-986196

Phase 1

Healthy Male Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Nov 13, 2023

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
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05981963A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Aug 17, 2023Oct 22, 2023Nov 13, 20231 United States
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Study Endpoints
Primary Endpoints
Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)
Up to Day 15
TRA: Time of Cmax (Tmax)
Up to Day 15
TRA: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to Day 15
TRA: Amount of radioactivity recovered in urine (UR)
Up to Day 15
TRA: Amount of radioactivity recovered in feces (FR)
Up to Day 15
TRA: Amount of radioactivity recovered in bile (BR)
Up to 14 hours post dose
TRA: Percent of administered dose recovered in urine (%UR)
Up to Day 15
TRA: Percent of administered dose recovered in feces (%FR)
Up to Day 15
TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)
Up to Day 15
Secondary Endpoints
Cmax
Up to Day 15
Tmax
Up to Day 15
AUC (0-T)
Up to Day 15
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-BMS-986196EXPERIMENTAL -
Interventions
NameTypeDescription
[14C]-BMS-986196DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination. * Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and t...

Countries:United States
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