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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
180 mg film coated tablet administered as FDC or co-administered with ezetimibe Component of FDC
10 mg tablet administered as FDC or co-administered with bempedoic acid Component of FDC
20 mg film coated tablet administered individually or as FDC Component of FDC
BlueClinical Phase I BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.
Porto, Portugal
Pharmacokinetic Parameter Area Under the Curve (AUC)
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.
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
Pharmacokinetic Parameter Maximum Observed Concentration (Cmax)
Maximum observed concentration will be assessed.
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
Pharmacokinetic Parameters (AUCinf)
AUC from time of dosing (t=0h) extrapolated to infinity (AUCinf) will be assessed using noncompartmental methods, where applicable.
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
Pharmacokinetic Parameters (AUClast/AUCinf)
AUClast/AUCinf will be assessed using noncompartmental methods, where applicable.
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
Pharmacokinetic Parameter Time to Reach Maximum Observed Concentration (Tmax)
Time to reach maximum observed concentration (Tmax) will be assessed.
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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
Pharmacokinetic Parameter Terminal Half-life (t1/2)
Terminal half-life (t1/2) will be assessed using noncompartmental methods, where applicable.
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
Pharmacokinetic Parameter First Order Rate Constant Associated With The Terminal Portion of the Concentration-Time Curve (Kel)
First order rate constant associated with the terminal portion of the concentration-time curve (Kel) was assessed using noncompartmental methods, where applicable.
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
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA).
Time frame: Baseline to end of study, up to approximately 2 months