This study aims to compare the PK of Navlimetostat after administration of a wet-granulation tablet versus the dry-granulation tablet formulation in healthy adult female
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Specified dose on specified days
CenExel iResearch - Decatur
Decatur, Georgia, United States
RECRUITINGLocal Institution - 0003
Decatur, Georgia, United States
WITHDRAWNLocal Institution - 0001
Austin, Texas, United States
WITHDRAWNMaximum Plasma Concentration (Cmax)
Time frame: Up to Day 17
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 17
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 17
Number of participants with Adverse Events (AE)
Time frame: Up to approximately day 37
Number of participants with Serious Adverse Events (AE)
Time frame: Up to approximately day 37
Number of participants with clinically significant changes in Physical Examinations (PE)
Time frame: Up to Day 17
Number of participants with clinically significant changes in vital signs (VS)
Time frame: Up to Day 17
Number of participants with clinically significant changes in 12-lead ECGs
Time frame: Up to Day 17
Number of participants with clinically significant changes in laboratory tests results
Time frame: Up to Day 17
Time of maximum observed drug concentration (Tmax)
Time frame: Up to Day 17
Terminal elimination half-life (T-HALF)
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Local Institution - 0004
Austin, Texas, United States
NOT_YET_RECRUITINGTime frame: Up to Day 17
Apparent total body clearance (CLT/F)
Time frame: Up to Day 17
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: Up to Day 17
Mean residence time (MRT)
Time frame: Up to Day 17