Healthy Female ParticipantsPhase 1NCT07777133
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 testing Navlimetostat and [14C]Navlimetostat in people with Healthy Female Participants, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Female Participants
- What is being tested?
- Navlimetostat and [14C]Navlimetostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Sep 2026to 5 Dec 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:.
- Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
2 sites in 2 countries
United States1 site
Local Institution - 0001
Madison, Wisconsin, 53704-2526
Site 0001
Netherlands1 site
Local Institution - 0002
Groningen, Provincie Groningen, 9728 NZ
Site 0002
About this study
Official title: 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
- Conditions
- Healthy Female Participants
- Being tested
- Navlimetostat, [14C]Navlimetostat
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NavlimetostatDrug
Also called BMS-986504
Specified dose on specified days
[14C]NavlimetostatDrug
Also called BMS-986504
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: Navlimetostat |
| Part B | Experimental | Not described Receives: Drug: [14C]Navlimetostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured: Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Measured: 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))
Measured: Up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured: Up to 14 days
Terminal elimination half-life (T-HALF)
Measured: Up to 14 days
Apparent total body clearance (CLT/F)
Measured: Up to 14 days
Apparent volume of distribution during the terminal phase (VZ/F)
Measured: Up to 14 days
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF))
Measured: Up to 14 days
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Measured: Up to 14 days
Total amount of dose recovered in urine (UR)
Measured: Up to 14 days
Percent of administered dose recovered in urine (%UR)
Measured: Up to 14 days
Renal clearance (CLR)
Measured: Up to 14 days
TRA from UR
Measured: Up to 14 days
TRA from %UR
Measured: Up to 14 days
TRA from total amount of dose recovered in feces (FR)
Measured: Up to 14 days
TRA from percent of administered dose recovered in feces (%FR)
Measured: Up to 14 days
TRA from total amount of radioactivity recovered (Rtotal)
Measured: Up to 14 days
TRA from total percent of radioactivity recovered (%TOTAL)
Measured: Up to 14 days
TRA amount recovered of the radioactive dose in vomit, if applicable
Measured: Up to 14 days
TRA fraction of the radioactive dose in vomit, if applicable
Measured: Up to 14 days
Secondary outcomes (12)
Cmax
Measured: Up to 14 days
Tmax
Measured: Up to 14 days
Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU))
Measured: Up to 14 days
Trough observed plasma concentration (Ctrough)
Measured: Up to 14 days
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)
Measured: Up to 14 days
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU))
Measured: Up to 14 days
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 14 days
Number of participants with serious adverse events (SAEs)
Measured: Up to 14 days
Number of participants with clinically significant changes in physical examinations
Measured: Up to 14 days
Number of participants with clinically significant changes in vital signs
Measured: Up to 14 days
Number of participants with clinically significant changes in 12-lead ECGs
Measured: Up to 14 days
Number of participants with clinically significant changes in clinical laboratory test results
Measured: Up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start16 Sep 2026 (estimated)
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Female ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777133
- Sponsor's protocol ID
- CA240-0049
- Status last verified
- Jul 2026
- First submitted
- 18 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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