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A 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 Participants

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NCT06568458

Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.

Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
71actual
Sites
1
Country
United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2024-09-19actualWhen the study began enrolling
Primary completion2025-02-27actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-02-27actualThe whole study's end, after follow-up
First posted2024-08-23actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-03-14actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Healthy Participants

Interventions

  • Drug: Nintedanib
  • Drug: BMS 986278

Primary outcomes

what the primary-completion date above is the date OF
Maximum Observed Serum Concentration (Cmax)
measured 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)
measured 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)
measured 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)
measured Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

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