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Trial ID CA240-0049  |   NCT07777133

A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants

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Summary

  • Phase 1
  • Female Gender icon
  • 18-55
    Age Range
  • 1
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

The purpose of this study is to evaluate the metabolism, the routes and extent of elimination, and drug levels of [14C]Navlimetostat (BMS-986504) in healthy female participants

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Key Eligibility Criteria

Inclusion Criteria

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  • Participants must have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
    1. Participants must have a recent history (ie, last month) of a minimum of 1 bowel movement per 2 days.
      1. Participants must be female (as assigned at birth) who is an individual not of childbearing potential (INOCBP), defined as one of the following:.
        1. Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
          1. Postmenopausal, defined as ≥ 12 consecutive months of amenorrhea in an individual over the age of 45 years (no other biological or physiological causes), and individuals < 55 years of age with 12 months of amenorrhea must have serum FSH levels > 40 mIU/mL at screening to confirm menopausal status.

          Exclusion Criteria

          Exclusion Criteria Icon
          • Participants must not have any significant acute or chronic medical illness.
            1. Participants must not have current or recent gastrointestinal disease.
              1. Participants must not have a history of prolonged bleeding or excessive bruising.
                Additional Information *
                • Other protocol-defined Inclusion/Exclusion criteria apply.

                  Treatment Options

                  Study Arms

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part A

                  ASSIGNED INTERVENTION

                  Study Arms

                  Experimental: Part B

                  ASSIGNED INTERVENTION
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