Healthy SubjectsPhase 1NCT07201545
Evaluating Bioequivalence of a Fixed Dose Combination Versus Tablets of Bempedoic Acid / Ezetimibe and Rosuvastatin
A Phase 1 study testing Bempedoic acid, Ezetimibe and Rosuvastatin in people with Healthy Subjects, run by Daiichi Sankyo at 1 site in Portugal.
Trial 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 low density lipoprotein cholesterol (LDL-C) lowering and atherosclerotic cardiovascular disease risk reduction in patients… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Bempedoic acid, Ezetimibe and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePortugal
- Study dates
- 7 Oct 2025to 10 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
BlueClinical Phase I BlueClinical - Investigação e Desenvolvimento em Saúde, Lda.
Porto, 4250-449
About this study
Official 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
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.
Read the 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 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.
- Conditions
- Healthy Subjects
- Being tested
- Bempedoic acid, Ezetimibe, Rosuvastatin
- Keywords
- Healthy Subjects, Bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic acidDrug
Also called Nilemdo®
180 mg film coated tablet administered as FDC or co-administered with ezetimibe
Component of FDC
EzetimibeDrug
Also called Ezetrol®
10 mg tablet administered as FDC or co-administered with bempedoic acid
Component of FDC
RosuvastatinDrug
Also called Crestor®
20 mg film coated tablet administered individually or as FDC
Component of FDC
| Study group | Role | What they receive |
|---|---|---|
| Test Formulation | Experimental | Healthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation). Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Rosuvastatin |
| Reference Formulation | Active comparator | Healthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation). Receives: Drug: Bempedoic acid; Drug: Ezetimibe; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Secondary outcomes (6)
Pharmacokinetic Parameters (AUCinf)
AUC from time of dosing (t=0h) extrapolated to infinity (AUCinf) will be assessed using noncompartmental methods, where applicable.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to end of study, up to approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start7 Oct 2025
- Primary completion10 Dec 2025
- Study completion10 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201545
- Sponsor's protocol ID
- DSE-BMP-0004-CIS-MA
- Other IDs
- 2024-519852-10-00
- Status last verified
- Dec 2025
- First submitted
- 23 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07201545
- Acronym / sponsor ID
- DSE-BMP-0004-CIS-MA
- Conditions
- Healthy Subjects
- Keywords
- Healthy Subjects, Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 10 Dec 2025 (actual)
- Study completion
- 10 Dec 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Formulation | Experimental | Drug: Bempedoic acid, Drug: Ezetimibe, Drug: RosuvastatinHealthy participants who are randomized to receive the fixed dose triplet combination with bempedoic acid 180 mg/ezetimibe 10 mg/rosuvastatin 20 mg (test formulation). |
| Reference Formulation | Active comparator | Drug: Bempedoic acid, Drug: Ezetimibe, Drug: RosuvastatinHealthy participants who are randomized to receive co-administration of bempedoic acid 180 mg/ezetimibe 10 mg + rosuvastatin 20 mg (reference formulation). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bempedoic acidAlso: Nilemdo®180 mg film coated tablet administered as FDC or co-administered with ezetimibe Component of FDC | Drug | Reference Formulation, Test Formulation |
| EzetimibeAlso: Ezetrol®10 mg tablet administered as FDC or co-administered with bempedoic acid Component of FDC | Drug | Reference Formulation, Test Formulation |
| RosuvastatinAlso: Crestor®20 mg film coated tablet administered individually or as FDC Component of FDC | Drug | Reference Formulation, Test Formulation |
Primary outcome
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.
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.
6 secondary outcomes
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
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
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
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
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
Number of Participants Reporting Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline to end of study, up to approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bempedoic acid, Ezetimibe and Rosuvastatin in people with Healthy Subjects, run by Daiichi Sankyo at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.