Status:
COMPLETED
Evaluating Bioequivalence of a Fixed Dose Combination Versus Individual Tablets of Bempedoic Acid, Ezetimibe, and Rosuvastatin
Lead Sponsor:
Daiichi Sankyo
Conditions:
Healthy Subjects
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
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 lowe...
Detailed Description
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 pro...
Eligibility Criteria
Inclusion
- 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 resulting in negative results, non-lactating status, and agree to use accepted contraceptive method from at least 4 weeks prior to admission to the first study period until the end of the study, 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).
- 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) ≤1.5 times 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.
Exclusion
Key Trial Info
Start Date :
September 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 24 2025
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT07182383
Start Date
September 29 2025
End Date
November 24 2025
Last Update
December 16 2025
Active Locations (1)
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1
Research Site
Porto, Portugal, 4250-449