The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Solid oral formulation of EDG-7500
Parexel
Glendale, California, United States
AUC0-last
Area under the plasma concentration time-curve from time zero to the last measured concentration
Time frame: Day 1 to Day 13
AUC0-inf
Area under the plasma concentration time-curve from time zero extrapolated to infinity
Time frame: Day 1 to Day 13
AUCtau
Area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
Cmax
Maximum plasma concentration observed
Time frame: Day 1 to Day 13
Cmax,ss
Maximum plasma concentration at steady state determined directly from the concentration-time profile
Time frame: Day 1 to Day 13
Safety - TEAEs
Incidence of treatment-emergent adverse events
Time frame: Up to 23 days of monitoring
Tmax
Time to maximum plasma concentration
Time frame: Day 1 to Day 13
AUC%extrap
Percentage of AUCinf obtained by extrapolation beyond time of the last quantifiable concentration (tlast)
Time frame: Day 1 to Day 13
CL/F
Total body clearance
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Time frame: Day 1 to Day 13
Vz/F
Apparent volume of distribution
Time frame: Day 1 to Day 13
T1/2
Terminal elimination half-life
Time frame: Day 1 to Day 13
Ctrough,ss
Trough plasma concentration at steady state
Time frame: Day 1 to Day 13
Cavg,ss
Average plasma drug concentration during a dosing interval at steady state
Time frame: Day 1 to Day 13
RA(AUCtau)
Accumulation ratio for the area under the concentration-time curve during the dosing interval
Time frame: Day 1 to Day 13
RA(Cmax)
Accumulation ratio at the maximum concentration
Time frame: Day 1 to Day 13