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
- 29 Sep 2026to 5 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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, 1 recruiting
- Not yet recruiting
Local Institution - 0002
Madison, Wisconsin, 53704-2526
Site 0002
Netherlands1 site, 1 recruiting
- Recruiting
ICON Netherlands - Groningen
Groningen, Provincie Groningen, 9728 NZ
Salah Hadi, Site 0001
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 start29 Sep 2026
- 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
- Nov 2026
- First submitted
- 18 Aug 2026
- Last updated
- 6 Nov 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07777133
- Acronym / sponsor ID
- CA240-0049
- 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
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 29 Sep 2026 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Navlimetostat |
| Part B | Experimental | Drug: [14C]Navlimetostat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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:.
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NavlimetostatAlso: BMS-986504Specified dose on specified days | Drug | Part A |
| [14C]NavlimetostatAlso: BMS-986504Specified dose on specified days | Drug | Part B |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 14 days
Time of maximum observed plasma concentration (Tmax)
Time frame: 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))
Time frame: Up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 14 days
Terminal elimination half-life (T-HALF)
Time frame: Up to 14 days
Apparent total body clearance (CLT/F)
Time frame: Up to 14 days
Apparent volume of distribution during the terminal phase (VZ/F)
Time frame: Up to 14 days
Percent of plasma navlimetostat AUC(INF) to plasma radioactivity AUC(INF) (%AUC(INF))
Time frame: Up to 14 days
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Time frame: Up to 14 days
Total amount of dose recovered in urine (UR)
Time frame: Up to 14 days
Percent of administered dose recovered in urine (%UR)
Time frame: Up to 14 days
Renal clearance (CLR)
Time frame: Up to 14 days
TRA from UR
Time frame: Up to 14 days
TRA from %UR
Time frame: Up to 14 days
TRA from total amount of dose recovered in feces (FR)
Time frame: Up to 14 days
TRA from percent of administered dose recovered in feces (%FR)
Time frame: Up to 14 days
TRA from total amount of radioactivity recovered (Rtotal)
Time frame: Up to 14 days
TRA from total percent of radioactivity recovered (%TOTAL)
Time frame: Up to 14 days
TRA amount recovered of the radioactive dose in vomit, if applicable
Time frame: Up to 14 days
TRA fraction of the radioactive dose in vomit, if applicable
Time frame: Up to 14 days
12 secondary outcomes
Cmax
Time frame: Up to 14 days
Tmax
Time frame: Up to 14 days
Area under the plasma concentration-time curve over 1 dosing interval (AUC(TAU))
Time frame: Up to 14 days
Trough observed plasma concentration (Ctrough)
Time frame: Up to 14 days
Ratio of metabolite Cmax to parent Cmax, corrected for molecular weight (MR_Cmax)
Time frame: Up to 14 days
Ratio of metabolite AUC(TAU) to parent AUC(TAU), corrected for molecular weight (MR_AUC(TAU))
Time frame: Up to 14 days
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 14 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 14 days
Number of participants with clinically significant changes in physical examinations
Time frame: Up to 14 days
Number of participants with clinically significant changes in vital signs
Time frame: Up to 14 days
Number of participants with clinically significant changes in 12-lead ECGs
Time frame: Up to 14 days
Number of participants with clinically significant changes in clinical laboratory test results
Time frame: Up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) (time frame: Up to 14 days). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.