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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECC4703 F1 formulation | Experimental | Participants will receive a single dose of ECC4703 F1 high-fat or fasted state, followed by ECC4703 F1 fasted or high-fat state, respectively, in subsequent treatment periods |
|
| ECC4703 F2 formulation | Experimental | Participants will receive a single dose of ECC4703 F2 high-fat or fasted state, followed by ECC4703 F2 fasted or high-fat state, respectively, in subsequent treatment periods |
|
| ECC4703 F3 formulation | Experimental | Participants will receive a single dose of ECC4703 F3 high-fat or fasted state, followed by ECC4703 F3 fasted or high-fat state, respectively, in subsequent treatment periods |
|
| ECC4703 F0 formulation | Experimental | Participants will receive a single dose of ECC4703 F0 fasted state, followed by ECC4703 F1, F2 or F3 fasted in subsequent treatment periods |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECC4703 F0 formulation | Drug | A single dose of ECC4703 F0 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ECC4703 pharmacokinetic (PK) parameters AUC0-tlast | Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non-Zero Concentration | Up to Day 13 |
| ECC4703 PK parameters AUC0-inf | Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity | Up to Day 13 |
| ECC4703 PK parameters Cmax | Maximum observed plasma concentration | Up to Day 13 |
| ECC4703 PK parameters tmax | Time of the maximum observed plasma concentration | Up to Day 13 |
| ECC4703 PK parameters AUC0-t | Area under the plasma concentration-time curve up to the last measurable concentration | Up to Day 13 |
| ECC4703 PK parameters AUC0-24 | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose | 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 | Up to Day 13 |
| ECC4703 PK parameters tlag |
| Measure | Description | Time Frame |
|---|---|---|
| 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 18 |
| ECC4703 PK parameters AUC0-t |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eccogene Clinical Trials | Contact | 86-21-61053022 | contact@eccogene.com |
| Name | Affiliation | Role |
|---|---|---|
| Eccogene Clinical Trials | Eccogene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Recruiting | Adelaide | South Australia | 5000 | Australia |
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| ECC4703 F1 formulation |
| Drug |
A single dose of ECC4703 F1 |
|
| ECC4703 F2 formulation | Drug | A single dose of ECC4703 F2 |
|
| ECC4703 F3 formulation | Drug | A single dose of ECC4703 F3 |
|
lag time (time delay between dosing and first observed plasma concentration)
| Up to Day 13 |
| ECC4703 PK parameters t1/2 | elimination half-life | Up to Day 13 |
| ECC4703 PK parameters CL/F | apparent clearance | Up to Day 13 |
area under the plasma concentration-time curve up to the last measurable concentration |
| Up to Day 13 |
| ECC4703 PK parameters AUC0-24 | Area under the plasma concentration-time curve from time 0 to 24 hours post-dose | 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 | Up to Day 13 |
| ECC4703 PK parameters tlag | lag time (time delay between dosing and first observed plasma concentration) | Up to Day 13 |
| ECC4703 PK parameters t1/2 | elimination half-life | Up to Day 13 |
| ECC4703 PK parameters CL/F | apparent clearance | Up to Day 13 |