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

• Navlimetostat (Drug), also known as BMS-986504: Specified dose on specified days
• [14C]Navlimetostat (Drug), also known as BMS-986504: Specified dose on specified days

Primary outcomes

• Maximum observed plasma concentration (Cmax) [Up to 14 days]
• Time of maximum observed plasma concentration (Tmax) [Up to 14 days]
• Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) [Up to 14 days]
• Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) [Up to 14 days]
• Terminal elimination half-life (T-HALF) [Up to 14 days]
• Apparent total body clearance (CLT/F) [Up to 14 days]
• Apparent volume of distribution during the terminal phase (VZ/F) [Up to 14 days]
• Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF)) [Up to 14 days]
• Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF) [Up to 14 days]
• Total amount of dose recovered in urine (UR) [Up to 14 days]
• Percent of administered dose recovered in urine (%UR) [Up to 14 days]
• Renal clearance (CLR) [Up to 14 days]
• TRA from UR [Up to 14 days]
• TRA from %UR [Up to 14 days]
• TRA from total amount of dose recovered in feces (FR) [Up to 14 days]
• TRA from percent of administered dose recovered in feces (%FR) [Up to 14 days]
• TRA from total amount of radioactivity recovered (Rtotal) [Up to 14 days]
• TRA from total percent of radioactivity recovered (%TOTAL) [Up to 14 days]
• TRA amount recovered of the radioactive dose in vomit, if applicable [Up to 14 days]
• TRA fraction of the radioactive dose in vomit, if applicable [Up to 14 days]

Secondary outcomes

• Cmax [Up to 14 days]
• Tmax [Up to 14 days]
• Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU)) [Up to 14 days]
• Trough observed plasma concentration (Ctrough) [Up to 14 days]
• Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax) [Up to 14 days]
• Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU)) [Up to 14 days]
• Number of participants with treatment-emergent adverse events (TEAEs) [Up to 14 days]
• Number of participants with serious adverse events (SAEs) [Up to 14 days]
• Number of participants with clinically significant changes in physical examinations [Up to 14 days]
• Number of participants with clinically significant changes in vital signs [Up to 14 days]
• Number of participants with clinically significant changes in 12-lead ECGs [Up to 14 days]
• Number of participants with clinically significant changes in clinical laboratory test results [Up to 14 days]

Sex: Female, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria

* Participants must have a body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive.
* Participants must have a recent history (ie, last month) of a minimum of 1 bowel movement per 2 days.
* Participants must be female (as assigned at birth) who is an individual not of childbearing potential (INOCBP), defined as one of the following:.

  i) Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

ii) 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

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

• Bristol-Myers Squibb, Study director, Bristol-Myers Squibb