Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin
- Conditions
- Healthy Subjects
- Interventions
- Registration Number
- NCT07201545
- Lead Sponsor
- Daiichi Sankyo
- Brief Summary
The recommended first-line treatment of cardiovascular disease is a statin monotherapy; however, combination therapies represent an opportunity for an individualized, patient centered approach to low density lipoprotein cholesterol (LDL-C) lowering and atherosclerotic cardiovascular disease risk reduction in patients unable to reach individualized serum LDL-C levels. This study will test the bioequivalence of a test fixed dose combination (FDC) product versus the co-administered individual reference products.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Formulation Bempedoic acid Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation). Test Formulation Ezetimibe Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation). Test Formulation Rosuvastatin Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation). Reference Formulation Bempedoic acid Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation). Reference Formulation Ezetimibe Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation). Reference Formulation Rosuvastatin Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation).
- Primary Outcome Measures
Name Time Method Pharmacokinetic Parameter Area Under the Curve (AUC) Pre-dose (t=0h), 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 Area under the curve (AUC) from time of dosing (t=0h) to time 72 hours (AUC72h) or AUC from time of dosing (t=0h) to the time of last measurable (non-zero) concentration (AUClast) will be assessed using noncompartmental methods.
Pharmacokinetic Parameter Maximum Observed Concentration (Cmax) Pre-dose (t=0h), 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 will be assessed.
- Secondary Outcome Measures
Name Time Method Pharmacokinetic Parameters (AUCinf) Pre-dose (t=0h), 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 AUC from time of dosing (t=0h) extrapolated to infinity (AUCinf) will be assessed using noncompartmental methods, where applicable.
Pharmacokinetic Parameters (AUClast/AUCinf) Pre-dose (t=0h), 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 AUClast/AUCinf will be assessed using noncompartmental methods, where applicable.
Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax) Pre-dose (t=0h), 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 Time to reach maximum observed concentration (Tmax) will be assessed.
Pharmacokinetic Parameter Terminal Half-life (t1/2) Pre-dose (t=0h), 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 Terminal half-life (t1/2) will be assessed using noncompartmental methods, where applicable.
Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel) Pre-dose (t=0h), 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 First order rate constant associated with the terminal portion of the concentration-time curve (Kel) was assessed using noncompartmental methods, where applicable.
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs) Baseline to end of study, up to approximately 2 months AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Trial Locations
- Locations (1)
Research Site
🇵🇹Porto, Portugal
Research Site🇵🇹Porto, Portugal