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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fixed Sequence 1 | Experimental | Participants will receive single dose of ECC5004 F1 at fasted state, followed by F2 at fasted state, F1 at fed state and F2 at fed state in four treatment periods. |
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| Fixed Sequence 2 | Experimental | Participants will receive a single dose of ECC5004 F2 at fasted state, followed by F1 at fasted state, F2 at fed state, and F1 at fed state with four treatment periods. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECC5004 | Drug | A single dose tablet of 50 mg of the current tablet formulation (F1) or new tablet formulation (F2) administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 6 |
| ECC5004 PK parameters: AUC0-tau |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eccogene | Eccogene Clinical Trials | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eccogene Investigational Site | Anaheim | California | 92801 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| D004700 | Endocrine System Diseases |