This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.
Part 1 will include 3 cohorts of 16 participants each, completing 2 single-dose crossover periods to assess food effect on ECC4703 formulations (F1, F2, and F3). Part 2 of the study will enroll approximately 24 participants to compare selected formulations from Part 1 to formulation (F0), using an adaptive design to finalize sequence, treatment periods, and food conditions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
A single dose of ECC4703 F0
A single dose of ECC4703 F1
A single dose of ECC4703 F2
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
RECRUITINGECC4703 pharmacokinetic (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 13
ECC4703 PK parameters AUC0-inf
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Time frame: Up to Day 13
ECC4703 PK parameters Cmax
Maximum observed plasma concentration
Time frame: Up to Day 13
ECC4703 PK parameters tmax
Time of the maximum observed plasma concentration
Time frame: Up to Day 13
ECC4703 PK parameters AUC0-t
Area under the plasma concentration-time curve up to the last measurable concentration
Time frame: Up to Day 13
ECC4703 PK parameters AUC0-24
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Time frame: Up to Day 13
ECC4703 PK parameters AUCextr
percentage of area under the concentration-time curve that is due to extrapolation from the last measurable concentration to infinity
Time frame: Up to Day 13
ECC4703 PK parameters tlag
lag time (time delay between dosing and first observed plasma concentration)
Time frame: Up to Day 13
ECC4703 PK parameters t1/2
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A single dose of ECC4703 F3
elimination half-life
Time frame: Up to Day 13
ECC4703 PK parameters CL/F
apparent clearance
Time frame: Up to Day 13
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 18
ECC4703 PK parameters AUC0-t
area under the plasma concentration-time curve up to the last measurable concentration
Time frame: Up to Day 13
ECC4703 PK parameters AUC0-24
Area under the plasma concentration-time curve from time 0 to 24 hours post-dose
Time frame: Up to Day 13
ECC4703 PK parameters AUCextr
percentage of area under the concentration-time curve that is due to extrapolation from the last measurable concentration to infinity
Time frame: Up to Day 13
ECC4703 PK parameters tlag
lag time (time delay between dosing and first observed plasma concentration)
Time frame: Up to Day 13
ECC4703 PK parameters t1/2
elimination half-life
Time frame: Up to Day 13
ECC4703 PK parameters CL/F
apparent clearance
Time frame: Up to Day 13