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-BMS-986368

Phase 1

Healthy Volunteers | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: May 13, 2024

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 Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06227975A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male ParticipantsPHASE1 COMPLETED 8 — — Feb 2, 2024Apr 3, 2024May 13, 20241 United States
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Study Endpoints
Primary Endpoints
Maximum observed concentration (Cmax)
Up to Day 15
Time of maximum observed concentration (Tmax)
Up to Day 15
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Up to Day 15
Total Radioactivity (TRA)
Up to Day 30
Secondary Endpoints
Number of participants with Adverse Events (AEs)
Up to Day 36
Number of participants with Serious AEs (SAEs)
Up to Day 36
Number of participants with AEs leading to discontinuation
Up to Day 36
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
[14C]-BMS-986368EXPERIMENTAL -
Interventions
NameTypeDescription
[14C]-BMS-986368DRUGSpecified 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 as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator. * Body mass index of 18.0 to 35.0 kg/m2, in...

Countries:United States
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