ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEccogene
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy male and female participants
Age of 18 to 65 years
BMI of 18.0 to 32.0 kg/m2 with a minimum body weight of 50.0 kg (110 lb) for males and 45.0 kg (99 lb) for females.
Female participants of childbearing potential must have negative serum pregnancy test at screening and a negative serum or urine pregnancy test prior to the first dose of study drug; use at least 1 highly effective method of contraception (e.g., hormonal contraception, intrauterine device, bilateral tubal occlusion, or vasectomized partner with confirmed success) during the study and for at least 90 days after the last dose of study drug; and refrain from egg donation or fertility treatments during the same period.
Disqualifiers
Females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 90 days after the study.
Concomitant participation in any investigational study of any nature
Blood loss of ≥470 mL for non-physiological reasons (i.e., trauma, blood collection, blood donation) within 3 months prior to the first dose of study drug, plasma donation within 2 weeks prior to the first dose, platelet donation within 6 weeks prior to the first dose, or plans to donate blood during this study or within 1 month after the last dose of study drug.
Clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems
Trial design
Design model
Crossover
Treatments tested in this trial
ECC4703 F0 formulation
DrugA single dose of ECC4703 F0
ECC4703 F1 formulation
DrugA single dose of ECC4703 F1
ECC4703 F2 formulation
DrugA single dose of ECC4703 F2
ECC4703 F3 formulation
DrugA single dose of ECC4703 F3
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: ECC4703 F1 formulationExperimental treatment 1 intervention
Group B: ECC4703 F2 formulationExperimental treatment 1 intervention
Group C: ECC4703 F3 formulationExperimental treatment 1 intervention
Group D: ECC4703 F0 formulationExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
ECC4703 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 132
ECC4703 PK parameters AUC0-inf
Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity
Time frame
Up to Day 133
ECC4703 PK parameters Cmax
Maximum observed plasma concentration
Time frame
Up to Day 134
ECC4703 PK parameters tmax
Time of the maximum observed plasma concentration
Time frame
Up to Day 13Secondary outcomes
1
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 182
ECC4703 PK parameters AUC0-t
area under the plasma concentration-time curve up to the last measurable concentration
Time frame
Up to Day 133
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 134
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 Source ClinicalTrials.gov