Eccogene Investigational Site
Anaheim, California, 92801, United States
NCT Number: NCT06268145
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
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose tablet of 50 mg of the current tablet formulation (F1) or new tablet formulation (F2) administered orally.
Time frame: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration
Time frame: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Time frame: Up to day 6
Maximum observed plasma concentration
Time frame: Up to day 6
Time of the maximum observed plasma concentration
Time frame: Up to Day 6
Safety Assessment evaluated through adverse events, laboratory evaluations, vital signs, ECGs, and physical examination.
Time frame: Up to day 6
Area under the Plasma Concentration-Time Curve during the Dosing Interval
Time frame: Up to day 6
Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose
Time frame: Up to day 6
Lag time (time delay between dosing and first observed plasma concentration)
Time frame: Up to day 6
Apparent terminal elimination half-life
Time frame: Up to day 6
Apparent Clearance
Time frame: Up to day 6
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
Eccogene
Industry
An Open-Label, Randomized, Single Dose, Crossover Clinical Study to Assess the Relative Bioavailability of Current Tablet Formulation (F1) Compared to New Tablet Formulation (F2) of ECC5004 and Food Effects on F1 and F2 of ECC5004 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03899883
Diabetes, Diabetes Complications
Aurora, Colorado, United States
View Trial DetailsNCT05313529
Cognition Disorders, Cognitive Dysfunction
Changzhou, Jiangsu, China
View Trial DetailsNCT05684341
Diabetes Mellitus, Diabetes Mellitus, Type 2
Changhua, Taiwan
View Trial DetailsNCT07255820
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Diabetes Mellitus
Karachi, Sindh, Pakistan
View Trial Details