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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519851-27-00 | Other Identifier | EU CT Number |
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Monotherapies for lowering LDL-C often do not achieve target lipid levels because they act on a single pathway, which may be insufficient in patients with high cardiovascular risk or complex lipid profiles. Triple combination therapies, targeting multiple mechanisms of cholesterol metabolism simultaneously, have demonstrated superior LDL-C reduction and better achievement of guideline recommended LDL-C goals. Additionally, combining treatments into a single regimen can improve patient adherence and compliance, further enhancing clinical outcomes. This study will test the bioequivalence of a test fixed dose combination (FDC) product versus the co-administered individual reference products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Formulation | Experimental | Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/atorvastatin 40 mg (test formulation). |
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| Reference Formulation | Active Comparator | Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + atorvastatin 40 mg (reference formulation). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bempedoic acid | Drug | 180 mg film coated tablet administered as FDC or co-administered with ezetimibe (Component of FDC) |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameter Area Under the Curve (AUC) | Area under the curve (AUC) from time of dosing (t=0hours) to time 72 hours (AUC72hours) or AUC from time of dosing (t=0hours) to the time of last measurable (non-zero) concentration (AUClast) will be assessed using noncompartmental methods. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration will be assessed. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters (AUCinf) | AUC from time of dosing (t=0hours) extrapolated to infinity (AUCinf) will be assessed using noncompartmental methods, where applicable. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
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A participant is not eligible for the study at Screening if he/she fulfills any of the exclusion criteria as specified in the protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Porto | 4250-449 | Portugal |
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| ID | Term |
|---|---|
| C581236 | 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid |
| D000069438 | Ezetimibe |
| D000069059 | Atorvastatin |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Ezetimibe | Drug | 10 mg tablet administered as FDC or co-administered with bempedoic acid (Component of FDC) |
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| Atorvastatin | Drug | 40 mg tablet administered as FDC or individually (Component of FDC) |
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| Pharmacokinetic Parameters (AUClast/AUCinf) | AUClast/AUCinf will be assessed using noncompartmental methods, where applicable. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax) | Time to reach maximum observed concentration (Tmax) will be assessed. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Pharmacokinetic Parameter Terminal Half-life (t1/2) | Terminal half-life (t1/2) will be assessed using noncompartmental methods, where appropriate. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel) | First order rate constant associated with the terminal portion of the concentration-time curve (Kel) will be assessed using noncompartmental methods, where appropriate. | Pre-dose (t=0hours), and at 0.17 hours (10 minutes), 0.5 hours, 0.75 hours, 1 hour, 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours (Day 2), 48 hours (Day 3), and 72 hours (Day 4) postdose |
| Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) | AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). | Baseline to end of study, approximately 57 days |
| D011758 |
| Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |