A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
← catalyst calendarNCT07777133 · readout in 106 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1
Status
Not yet recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
6estimated
Sites
2
Countries
Netherlands, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-20
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-09-16 | estimated | When the study began enrolling |
| Primary completion | 2026-12-05 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-05 | estimated | The whole study's end, after follow-up |
| First posted | 2026-08-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Female Participants
Interventions
- Drug: Navlimetostat — also filed as BMS-986504
- Drug: [14C]Navlimetostat — also filed as BMS-986504
Primary outcomes
what the primary-completion date above is the date OFMaximum 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
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