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Nintedanib

Phase 1

Healthy Participants | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Mar 14, 2025

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
CONTROLLED
Total Trials1
Total Enrollment71
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06568458A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy ParticipantsPHASE1 COMPLETED 71 — — Sep 19, 2024Feb 27, 2025Mar 14, 20251 United States
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Study Endpoints
Primary Endpoints
Maximum Observed Serum Concentration (Cmax)
Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
Day 4, 17 and 21 of Part 1
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Secondary Endpoints
Number of participants with non-serious AEs (Adverse events)
Up to 28 Days post discontinuation of dosing
Number of participants with Serious AEs
Up to 28 Days post discontinuation of dosing
Number of participants with AEs leading to discontinuation
Up to 28 Days post discontinuation of dosing
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part I: Period AEXPERIMENTAL -
Part I: Period BEXPERIMENTAL -
Part I: Period CEXPERIMENTAL -
Part II: Period 1EXPERIMENTAL -
Part II: Period 2EXPERIMENTAL -
Part II: Period 3EXPERIMENTAL -
Part III: Period 1EXPERIMENTAL -
Part III: Period 2EXPERIMENTAL -
Interventions
NameTypeDescription
NintedanibDRUGSpecified Dose on specified days
BMS 986278DRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants must be healthy males and females (INOCBP) * Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive. * Participant must have Body weight ≥ 50 kg Exclusion Criteria: * Participant must not have current or recent GI disease * Parti...

Countries:United States
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