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

A Phase 1 Study to Evaluate the Mass Balance, Metabolism, Excretion, and Pharmacokinetics of [14C]Navlimetostat (BMS-986504) at Steady State in Healthy Female Participants

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Female Participants
• Intervention / Treatment: Drug: Navlimetostat; Drug: [14C]Navlimetostat

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• Netherlands
  • Provincie Groningen
    • Groningen, Provincie Groningen, Netherlands, 9728 NZ
      • Recruiting
      • ICON Netherlands - Groningen
      • Contact: Salah Hadi, Site 0001
• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Not yet recruiting
      • Local Institution - 0002
      • Contact: Site 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A	Drug: Navlimetostat; Specified dose on specified days; Other Names: BMS-986504
Experimental: Part B	Drug: [14C]Navlimetostat; Specified dose on specified days; Other Names: BMS-986504

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Trough observed plasma concentration (Ctrough)	Up to 14 days
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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• <p>BMS Clinical Trial Information</p>
• <p>BMS Clinical Trial Patient Recruiting</p>

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026

Study Registration Dates

• First Submitted: August 18, 2026
• First Submitted That Met QC Criteria: August 18, 2026
• First Posted (Actual): August 20, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 4, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Distribution; Absorption; Metabolism; Elimination; Excretion; Radiolabeled; Protein arginine methyltransferase (PRMT5); Methylthioadenosine-cooperative PRMT5 inhibitor; Homozygous methylthioadenosine phosphorylase (MTAP) deletion; Mass balance study; Drug absorption; Excretion (ADME); Navlimtostat
• Other Study ID Numbers: CA240-0049

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No