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Trial ID IM027-1026  |   NCT06568458

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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-65
    Age Range
  • 2
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • Participants must be healthy males and females (INOCBP)
    1. Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
      1. Participant must have Body weight ≥ 50 kg

        Exclusion Criteria

        Exclusion Criteria Icon
        :
        • Participant must not have current or recent GI disease
          1. Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
            1. Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
              Additional Information *
              • Other protocol-defined Inclusion/Exclusion criteria apply.

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Part I: Period A

                ASSIGNED INTERVENTION
                • Drug: Nintedanib

                Study Arms

                Experimental: Part I: Period B

                ASSIGNED INTERVENTION
                • Drug: BMS 986278

                Study Arms

                Experimental: Part I: Period C

                ASSIGNED INTERVENTION
                • Drug: Nintedanib, BMS 986278

                Study Arms

                Experimental: Part II: Period 1

                ASSIGNED INTERVENTION
                • Drug: BMS 986278

                Study Arms

                Experimental: Part II: Period 2

                ASSIGNED INTERVENTION
                • Drug: BMS 986278

                Study Arms

                Experimental: Part II: Period 3

                ASSIGNED INTERVENTION
                • Drug: BMS 986278

                Study Arms

                Experimental: Part III: Period 1

                ASSIGNED INTERVENTION
                • Drug: BMS 986278

                Study Arms

                Experimental: Part III: Period 2

                ASSIGNED INTERVENTION
                • Drug: BMS 986278
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