A Phase 1 interventional study of Navlimetostat and [14C]Navlimetostat in Healthy Female Participants, sponsored by Bristol-Myers Squibb. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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
Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants must be female (as assigned at birth) who is an individual not of (INOCBP), defined as one of the following:.
i) Surgically sterile (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
ii) , 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Navlimetostat
Drug: [14C]Navlimetostat
Specified dose on specified days
Also known as: BMS-986504
Specified dose on specified days
Also known as: BMS-986504
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
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
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Navlimetostat