Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin

Not Applicable

Not yet recruiting

• Conditions: Healthy Subjects
• Interventions: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Rosuvastatin

• Registration Number: NCT07182383
• 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 lower low density lipoprotein cholesterol (LDL-C) and reduce atherosclerotic cardiovascular disease risk in patients unable to reach individualized serum LDL-C levels. This study will test the bioequivalence of a test fixed dose combination (FDC) vs the co-administration of individual tablets.

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.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-11
• Study First Submitted QC: 2025-09-11
• Study First Posted: 2025-09-19
• Last Update Submitted: 2025-09-23
• Study Start: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2025-11-18
• Study Completion: 2025-11-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Not provided

Exclusion Criteria

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	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	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	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) post-dose	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) post-dose	Maximum observed concentration will be assessed.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters (AUCinf and 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) post-dose	AUC from time of dosing (t=0h) extrapolated to infinity (AUCinf) and AUClast/AUCinf will be assessed using noncompartmental methods.
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) post-dose	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) post-dose	Terminal half-life (t1/2) will be assessed using noncompartmental methods.
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) post-dose	First order rate constant associated with the terminal portion of the concentration-time curve (Kel) was assessed using noncompartmental methods.
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