A Study Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Atorvastatin

Not Applicable

Recruiting

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

• Registration Number: NCT07235189
• Lead Sponsor: Daiichi Sankyo

Brief Summary

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) vs the coadministration of individual tablets.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-10-28
• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-19
• Last Update Posted: 2025-11-19
• Primary Completion: 2026-01-21
• Study Completion: 2026-01-21

Recruitment & Eligibility

• Status: 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/atorvastatin 40 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/atorvastatin 40 mg (test formulation).
Test Formulation	Atorvastatin	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).
Reference Formulation	Bempedoic acid	Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg + ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).
Reference Formulation	Ezetimibe	Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg + ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).
Reference Formulation	Atorvastatin	Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg + ezetimibe 10 mg + atorvastatin 40 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.
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.
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.
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 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.
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.
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)	Baseline to end of study, approximately 82 days	AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).

Trial Locations

Locations (1)

Research Site; 🇵🇹 Porto, Portugal