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Clinical Trial Details

Trial ID: L6752
Source ID: NCT06268145
Associated Drug: Ecc5004
Title: ECC5004 RBA FE Study in Healthy Participants
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: ECC5004
Outcome Measures: Primary: ECC5004 PK parameters: AUC0-tlast, Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration, Up to day 6|ECC5004 PK parameters: AUC0-inf, Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity, Up to day 6|ECC5004 PK parameters: Cmax, Maximum observed plasma concentration, Up to day 6|ECC5004 PK parameters: tmax, Time of the maximum observed plasma concentration, Up to day 6 | Secondary: 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., Up to Day 6|ECC5004 PK parameters: AUC0-tau, Area under the Plasma Concentration-Time Curve during the Dosing Interval, 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, Up to day 6|ECC5004 PK parameters: tlag, Lag time (time delay between dosing and first observed plasma concentration), Up to day 6|ECC5004 PK parameters: t1/2, Apparent terminal elimination half-life, Up to day 6|ECC5004 PK parameters: CL/F, Apparent Clearance, 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, Up to day 6
Sponsor/Collaborators: Sponsor: Eccogene
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 14
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-02-06
Completion Date: 2024-03-29
Results First Posted:
Last Update Posted: 2024-07-17
Locations: Eccogene Investigational Site, Anaheim, California, 92801, United States
URL: https://clinicaltrials.gov/show/NCT06268145