This study is a Phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ECC5004 current tablet formulation (F1) and 50 mg ECC5004 new tablet formulation (F2) under fasted and fed conditions in healthy participants
Eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. In the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2. In the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ECC5004 F1 or 50 mg ECC5004 F2
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
A single dose tablet of 50 mg of the current tablet formulation (F1) or new tablet formulation (F2) administered orally.
Eccogene Investigational Site
Anaheim, California, United States
ECC5004 PK parameters: AUC0-tlast
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
Time frame: Up to day 6
ECC5004 PK parameters: AUC0-inf
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Time frame: Up to day 6
ECC5004 PK parameters: Cmax
Maximum observed plasma concentration
Time frame: Up to day 6
ECC5004 PK parameters: tmax
Time of the maximum observed plasma concentration
Time frame: Up to day 6
Number of participants with adverse events, with abnormal laboratory test results, abnormal ECGs, abnormal vital signs, and abnormal physical examinations
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Time frame: Up to Day 6
ECC5004 PK parameters: AUC0-tau
Area under the Plasma Concentration-Time Curve during the Dosing Interval
Time frame: Up to day 6
ECC5004 PK parameters: AUC 0-24
Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose
Time frame: Up to day 6
ECC5004 PK parameters: tlag
Lag time (time delay between dosing and first observed plasma concentration)
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Time frame: Up to day 6
ECC5004 PK parameters: t1/2
Apparent terminal elimination half-life
Time frame: Up to day 6
ECC5004 PK parameters: CL/F
Apparent Clearance
Time frame: Up to day 6
ECC5004 PK parameters: AUC(extr)
Area under the curve from the first measured concentration value back extrapolated to the concentration value at time zero as a percentage of the area under the curve extrapolated to infinity using the predicted value of the last non-zero concentration
Time frame: Up to day 6