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

Daiichi Sankyo

Status and phase: Active, not recruiting; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Ezetimibe; Drug: Atorvastatin; Drug: Bempedoic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT07268625

DSE-BMP-0003-CIS-MA

2024-519851-27-00 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

1. Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent.
2. Body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
3. Female participants of childbearing potential agree to undergo pregnancy tests, and if with a non-vasectomized nor infertile male partner, agree to use an appropriate method of contraception (i.e., abstinence, hormonal, intrauterine device, bilateral tubal occlusion).
4. No clinically relevant diseases captured in medical history.
5. No clinically relevant abnormalities on physical examination.
6. No clinically relevant abnormalities on vital signs.
7. No clinically relevant abnormalities on 12-lead electrocardiogram (ECG).
8. No clinically relevant abnormalities on clinical laboratory tests.
9. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN).
10. Estimated renal creatinine clearance (CrCl) above the lower limit of normal range, based on creatinine clearance calculation by the Cockcroft-Gault formula and normalized to an average body surface area of 1.73 m^2.
11. Willingness to accept and comply with all study procedures and restrictions.
12. Non-smoker or ex-smoker (i.e., someone who abstained from using tobacco- or nicotine-containing products for at least 3 months prior to Screening).

A participant is not eligible for the study at Screening if he/she fulfills any of the exclusion criteria as specified in the protocol.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Test Formulation

Experimental group

Description:

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).

Treatment:

Drug: Bempedoic acid

Drug: Atorvastatin

Drug: Ezetimibe

Reference Formulation

Active Comparator group

Description:

Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).

Treatment:

Drug: Bempedoic acid

Drug: Atorvastatin

Drug: Ezetimibe