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Trial ID CN009-1024  |   NCT06144697

A Study to Evaluate the Safety, Tolerability, Drug Levels, Food, Formulation, and pH Effects on Relative Absorption of BMS-986465 and Its Active Derivative BMS-986464 in Healthy Participants

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to evaluate safety, tolerability, drug and food effects on relative bioavailability of BMS-986465 and its active derivative BMS-986464 in healthy participants and healthy participants of Japanese ethnicity.

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Key Eligibility Criteria

Inclusion Criteria

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:
  • Healthy male and female (i e, women not of childbearing potential) participants
    1. Body Mass Index (BMI) of 18 to 32 kg^m2 and total body weight ≥ 50 kg
      1. Parts A, B, and D: Participants without restriction on ethnicity
        1. Part C: Participants of Japanese ethnicity (both biological parents are ethnically Japanese)

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • Clinically significant medical, psychiatric and/or sound social reason, as determined by the investigator
            1. Any major surgery within 3 months of study intervention administration
              1. Participation in another clinical trial concurrent with this study Note: Other protocol-defined inclusion/exclusion criteria apply
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Part A: Single Ascending Dose (SAD) [BMS-986465 or placebo]

                ASSIGNED INTERVENTION
                • Drug: BMS-986465
                • Other: Placebo

                Study Arms

                Experimental: Part B: Multiple Ascending Dose (MAD) [BMS-986465 or placebo, Pegasys]

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: Part C: MAD in Japanese ethnicity [BMS-986465 or placebo]

                ASSIGNED INTERVENTION
                • Drug: BMS-986465
                • Other: Placebo

                Study Arms

                Experimental: Part D: Food/Formulation/pH Effects [BMS-986465, Famotidine]

                ASSIGNED INTERVENTION

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