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

NCT07777133 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CA240-0049
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Healthy Female Participants

Keywords

Protein arginine methyltransferase (PRMT5); Methylthioadenosine-cooperative PRMT5 inhibitor; Homozygous methylthioadenosine phosphorylase (MTAP) deletion; Mass balance study; Metabolism; Elimination; Drug absorption; Distribution; Excretion; Radiolabeled; Absorption; Excretion (ADME); Navlimtostat

Outcome Measures

Primary Outcomes (20)

• 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 (12)

• 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

Study Arms (2)

Part A

EXPERIMENTAL

Drug: Navlimetostat

Part B

EXPERIMENTAL

Drug: [14C]Navlimetostat

Interventions

Navlimetostat DRUG

Specified dose on specified days

Also known as: BMS-986504

Part A

[14C]Navlimetostat DRUG

Specified dose on specified days

Also known as: BMS-986504

Part B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution - 0001

Madison, Wisconsin, 53704-2526, United States

Location

Local Institution - 0002

Groningen, Provincie Groningen, 9728 NZ, Netherlands

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 20, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): December 5, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

NL (1); US (1)