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This is a Phase 1, open-label, non-randomized, fixed sequence study designed to evaluate the effect of ECC5004 on single dose pharmacokinetics of Atorvastatin, Rosuvastatin, Digoxin and Midazolam in healthy participants.
The study consists of four parts (Part A, Part B, optional Part C and optional Part D), each with approximately 16 healthy participants enrolled. Part A and optional Part C of the study will have the same study design with two treatment periods, except that ECC5004 will be administered at a higher dose level in the optional Part C. Part B and optional Part D of the study will have the same study design with five treatment periods, except that ECC5004 will be administered at a higher dose level in optional Part D. Rosuvastatin and Digoxin will be administered alone or in combination with EC5004 in Part A and optional Part C. Atorvastatin and Midazolam will be administered alone or in combination with ECC5004 in Part B and optional Part D. The conduct of Part C and Part D with an increased dose of ECC5004 may be conducted as optional parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin, Rosuvastatin, ECC5004 (Part A) | Experimental | Part A consists of 2 treatment periods. Participants will receive Digoxin and Rosuvastatin administered alone in treatment period 1 and in combination with ECC5004 in treatment period 2. |
|
| Midazolam, Atorvastatin, ECC5004 (Part B) | Experimental | Part B consists of 5 treatment periods. In treatment period 1, participants will receive Midazolam administered alone followed by treatment period 2 in which participants will receive Atorvastatin administered alone. In treatment period 3, participants will receive ECC5004 alone. In treatment period 4, participants will receive ECC5004 in combination with Midazolam. In treatment period 5, ECC5004 will be administered alone and co-administered with Atorvastatin. |
|
| Digoxin, Rosuvastatin, ECC5004 (optional Part C) | Experimental | Optional Part C consists of 2 treatment periods. Participants will receive Digoxin and Rosuvastatin administered alone in treatment period 1 and in combination with ECC5004 in treatment period 2. |
|
| Midazolam, Atorvastatin, ECC5004 (optional Part D) | Experimental | Optional Part D consists of 5 treatment periods. In treatment period 1, participants will receive Midazolam administered alone followed by treatment period 2 in which participants will receive Atorvastatin administered alone. In treatment period 3, participants will receive ECC5004 alone. In treatment period 4, participants will receive ECC5004 in combination with Midazolam. In treatment period 5, ECC5004 will be administered alone and co-administered with Atorvastatin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECC5004 | Drug | ECC5004 tablet will be administered orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Atorvastatin PK parameters: AUC(0-tlast) | Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration | Part B and optional Part D: up to Day 34 |
| Atorvastatin PK parameters: AUC(0-inf) | Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity | Part B and optional Part D: up to Day 34 |
| Atorvastatin PK parameters: Cmax | Maximum observed plasma concentration | Part B and optional Part D: up to Day 34 |
| Rosuvastatin PK parameters: AUC(0-tlast) | Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration | Part A and optional Part C: up to Day 11 |
| Rosuvastatin PK parameters: AUC(0-inf) | Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity | Part A and optional Part C: up to Day 11 |
| Rosuvastatin PK parameters: Cmax | Maximum observed plasma concentration | Part A and optional Part C: up to Day 11 |
| Digoxin PK parameters: AUC(0-tlast) | Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration | Part A and optional Part C: up to Day 11 |
| Measure | Description | Time Frame |
|---|---|---|
| ECC5004 Safety parameters: Number of participants with adverse events (AEs) | Safety Assessment evaluated through adverse events | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 |
| ECC5004 Safety parameters: Number of participants with vital sign abnormalities |
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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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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D000068718 | Rosuvastatin Calcium |
| D004077 | Digoxin |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Midazolam | Drug | Midazolam will be administered orally. |
|
| Rosuvastatin | Drug | Rosuvastatin will be administered orally. |
|
| Digoxin | Drug | Digoxin will be administered orally. |
|
| Atorvastatin | Drug | Atorvastatin will be administered orally. |
|
| Digoxin PK parameters: AUC(0-inf) | Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity | Part A and optional Part C: up to Day 11 |
| Digoxin PK parameters: Cmax | Maximum observed plasma concentration | Part A and optional Part C: up to Day 11 |
| Midazolam PK parameters: AUC(0-tlast) | Area under the Plasma Concentration-Time Curve from Time 0 to the Last Measurable Non Zero Concentration | Part B and optional Part D: up to Day 34 |
| Midazolam PK parameters: AUC(0-inf) | Area under the Plasma Concentration-Time Curve from Time 0 Extrapolated to Infinity | Part B and optional Part D: up to Day 34 |
| Midazolam PK parameters: Cmax | Maximum observed plasma concentration | Part B and optional Part D: up to Day 34 |
Safety Assessment evaluated through vital signs |
| Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 |
| ECC5004 Safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Safety Assessment evaluated through electrocardiograms (ECGs) | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 |
| ECC5004 Safety parameters: Number of participants with physical examination abnormalities | Safety Assessment evaluated through physical examination | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 |
| ECC5004 Safety parameters: Number of participants with clinical laboratory abnormalities | Safety Assessment evaluated through clinical laboratory assessments | Part A and optional Part C: up to Day 16; Part B and optional Part D: up to Day 40 |
| Atorvastatin safety parameters: Number of participants with adverse events (AEs) | Safety Assessment evaluated through adverse events | Part B and optional Part D: up to Day 40 |
| Atorvastatin safety parameters: Number of participants with vital sign abnormalities | Safety Assessment evaluated through vital signs | Part B and optional Part D: up to Day 40 |
| Atorvastatin safety parameters: Number of participants with electrocardiogram (ECG) | Safety Assessment evaluated through electrocardiograms (ECGs) | Part B and optional Part D: up to Day 40 |
| Atorvastatin safety parameters: Number of participants with physical examination abnormalities | Safety Assessment evaluated through physical examination | Part B and optional Part D: up to Day 40 |
| Atorvastatin safety parameters: Number of participants with clinical laboratory abnormalities | Safety Assessment evaluated through clinical laboratory assessments | Part B and optional Part D: up to Day 40 |
| Rosuvastatin safety parameters: Number of participants with adverse events (AEs) | Safety Assessment evaluated through adverse events | Part A and optional Part C: up to Day 16 |
| Rosuvastatin safety parameters: Number of participants with vital sign abnormalities | Safety Assessment evaluated through vital signs | Part A and optional Part C: up to Day 16 |
| Rosuvastatin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Safety Assessment evaluated through electrocardiograms (ECGs) | Part A and optional Part C: up to Day 16 |
| Rosuvastatin safety parameters: Number of participants with physical examination abnormalities | Safety Assessment evaluated through physical examination | Part A and optional Part C: up to Day 16 |
| Rosuvastatin safety parameters: Number of participants with clinical laboratory abnormalities | Safety Assessment evaluated through clinical laboratory assessments | Part A and optional Part C: up to Day 16 |
| Digoxin safety parameters: Number of participants with adverse events (AEs) | Safety Assessment evaluated through adverse events | Part A and optional Part C: up to Day 16 |
| Digoxin safety parameters: Number of participants with vital sign abnormalities | Safety Assessment evaluated through vital signs | Part A and optional Part C: up to Day 16 |
| Digoxin safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Safety Assessment evaluated through electrocardiograms (ECGs) | Part A and optional Part C: up to Day 16 |
| Digoxin safety parameters: Number of participants with physical examination abnormalities | Safety Assessment evaluated through physical examination | Part A and optional Part C: up to Day 16 |
| Digoxin safety parameters: Number of participants with clinical laboratory abnormalities | Safety Assessment evaluated through clinical laboratory assessments | Part A and optional Part C: up to Day 16 |
| Midazolam safety parameters: Number of participants with adverse events (AEs) | Safety Assessment evaluated through adverse events | Part B and optional Part D: up to Day 40 |
| Midazolam safety parameters: Number of participants with vital sign abnormalities | Safety Assessment evaluated through vital signs | Part B and optional Part D: up to Day 40 |
| Midazolam safety parameters: Number of participants with electrocardiogram (ECG) abnormalities | Safety Assessment evaluated through electrocardiograms (ECGs) | Part B and optional Part D: up to Day 40 |
| Midazolam safety parameters: Number of participants with physical examination abnormalities | Safety Assessment evaluated through physical examination | Part B and optional Part D: up to Day 40 |
| Midazolam safety parameters: Number of participants with clinical laboratory abnormalities | Safety Assessment evaluated through clinical laboratory assessments | Part B and optional Part D: up to Day 40 |
| ECC5004 PK parameters: AUC (0-τ) | Area under the Plasma Concentration-Time Curve during the Dosing Interval | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| ECC5004 PK parameters: AUC(0-24) | Area under the Plasma Concentration-Time Curve from Time 0 to 24 Hours Post-dose | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| ECC5004 PK parameters: tmax | Time of the maximum observed plasma concentration | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| ECC5004 PK parameters: t1/2 | Apparent terminal elimination half-life | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| ECC5004 PK parameters: CL/F | Apparent Clearance | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| ECC5004 PK parameters: Ctau | Observed Concentration at the End of the Dosing Interval | Part A and optional Part C: up to Day 11; Part B and optional Part D: up to Day 34 |
| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |