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

Sponsor
Daiichi Sankyo
Study ID
NCT07268625
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Subjects

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Bempedoic acid — DRUG
    180 mg film coated tablet administered as FDC or co-administered with ezetimibe (Component of FDC)
  • Ezetimibe — DRUG
    10 mg tablet administered as FDC or co-administered with bempedoic acid (Component of FDC)
  • Atorvastatin — DRUG
    40 mg tablet administered as FDC or individually (Component of FDC)

Study Details

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.

Key Dates

Start date
Dec 9, 2025
Status verified
Feb 2026
Primary completion
Feb 24, 2026
Completion
Feb 24, 2026

Study Design

Enrollment
58 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Test Formulation
    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).
  • Active Comparator: Reference Formulation
    Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + atorvastatin 40 mg (reference formulation).

Primary Outcome Measure

Pharmacokinetic Parameter Area Under the Curve (AUC) [ Time Frame: Pre-dose (t=0hours), 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 ]

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