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Completed

NCT Number: NCT07201545

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BlueClinical Phase I BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.

Porto, 4250-449, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

A participant is eligible for the study if he/she fulfills all of the following inclusion criteria:

  • Healthy male and female participants ≥18 and ≤60 years, at the time of signing the informed consent.
  • Body mass index (BMI) ≥18.5 and ≤30.0 kg/m^2.
  • 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.
  • No clinically relevant diseases captured in medical history.
  • No clinically relevant abnormalities on physical examination.
  • No clinically relevant abnormalities on vital signs.
  • No clinically relevant abnormalities on 12-lead electrocardiogram (ECG).
  • No clinically relevant abnormalities on clinical laboratory tests.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) above the upper limit of normal range (ULN).
  • 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.
  • Willingness to accept and comply with all study procedures and restrictions.
  • 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).
  • Ability to comprehend and willingness to freely sign the informed consent.

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

Treatment and study plan

Bempedoic acid

Drug

180 mg film coated tablet administered as FDC or co-administered with ezetimibe

Component of FDC

Other names: Nilemdo®

ezetimibe

Drug

10 mg tablet administered as FDC or co-administered with bempedoic acid

Component of FDC

Other names: Ezetrol®

Rosuvastatin

Drug

20 mg film coated tablet administered individually or as FDC

Component of FDC

Other names: Crestor®

Primary outcomes

  1. Pharmacokinetic Parameter Area Under the Curve (AUC)

    Time frame: 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.

  2. Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)

    Time frame: 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 outcomes

  1. Pharmacokinetic Parameters (AUCinf)

    Time frame: 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.

  2. Pharmacokinetic Parameters (AUClast/AUCinf)

    Time frame: 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.

  3. Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax)

    Time frame: 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.

  4. Pharmacokinetic Parameter Terminal Half-life (t1/2)

    Time frame: 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.

  5. Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel)

    Time frame: 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.

  6. Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)

    Time frame: Baseline to end of study, up to approximately 2 months

    AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Registry information

Official study title

A Randomized, Single-center, Open-label, Single-dose, 4-period, 2-sequence, Fully Replicate Crossover Study to Assess the Bioequivalence of a Test Fixed Dose Combination Product Versus the Co-administered Individual Reference Products Containing Bempedoic Acid 180 mg / Ezetimibe 10 mg and Rosuvastatin 20 mg in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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