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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Madison, Wisconsin, United States
Local Institution - 0002
Groningen, Provincie Groningen, Netherlands
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)
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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