HypercholesterolaemiaPhase 1NCT06923956
Single Dose Oral Bioequivalence Study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated Tablets in Healthy Adult Human Subjects Under Fasting Conditions.
A Phase 1 study testing Bempedoic Acid Film Coated Tablet and Nilemdo® (Bempedoic Acid) Film-coated tablets in people with Hypercholesterolaemia and Mixed Dyslipidaemia, run by Humanis Saglık Anonim Sirketi at 1 site in India.
Trial summary
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolaemia, Mixed Dyslipidaemia, Cardiovascular Diseases
- What is being tested?
- Bempedoic Acid Film Coated Tablet and Nilemdo® (Bempedoic Acid) Film-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteIndia
- Study dates
- 4 Dec 2024to 8 Feb 2025
- Phase
- Phase 1
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: 18 to 55 years old, both inclusive.
- Gender: Male and/or non-pregnant, non-lactating female.
- Female of child-bearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to first dosing day. They must be using an acceptable form of contraception.
- For female of child-bearing potential, acceptable forms of contraception include the following:
- Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period, or
- Barrier methods containing or used in conjunction with a spermicidal agent, or
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- Surgical sterilization or
- Practicing sexual abstinence throughout the course of the study.
- Female will not be considered of child-bearing potential if one of the following is reported and documented on the medical history:
- Postmenopausal with spontaneous amenorrhea for at least one year, or
- Spontaneous amenorrhea for more than 6 months and less than one year with Serum Follicular Stimulating Hormone (FSH) level > 40 mIU/mL, or
- Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
- Total hysterectomy and an absence of bleeding for at least 3 months.
- BMI: 18.5 to 30.0 kg/m2, both inclusive; BMI value should be rounded off to one significant digit after decimal point (e.g. 30.04 rounds down to 30.0, while 18.45 rounds up to 18.5).
- Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study).
- Able to communicate effectively with study personnel.
- Willing to provide written informed consent to participate in the study.
- All volunteers must be judged by the principal or sub-investigator or physician as normal and healthy during a pre-study safety assessment performed within 28 days of the first dose of study medication which will include:
Who cannot join
- History of allergic responses to Bempedoic acid or other related drugs, or any of its formulation ingredients.
- Have significant diseases or clinically significant abnormal findings during screening [medical history, physical examination (clinical examination), laboratory evaluations, ECG recording, gynecological history and examination (including pelvic examination and routine breast examination) (for female volunteers)].
- Any disease or condition like diabetes, psychosis or others, which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, respiratory, central nervous system or any other body system.
- History or presence of bronchial asthma.
- Use of any hormone replacement therapy within 3 months prior to the first dose of study medication.
- Use of any depot injection or implant of any drug within 3 months prior to the first dose of study medication.
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- Use of CYP enzyme inhibitors or inducers within 30 days prior to the first dose of study medication (see https://drug-interactions.medicine.iu.edu/MainTable.aspx).
- History or evidence of drug dependence or of alcoholism or of moderate alcohol use.
- History of difficulty with donating blood or difficulty in accessibility of veins.
- A positive hepatitis screen (includes subtypes B \& C).
- A positive test result for HIV antibody.
- Volunteer who have received a known investigational drug within seven elimination half-life of the administered drug prior to the first dose of study medication.
- Volunteer who have donated blood or loss of blood 50 ml to 100 ml within 30 days or 101 ml to 200 ml within 60 days or >200 ml within 90 days (excluding volume drawn at screening for this study) prior to first dose of study medication, whichever is greater.
- History of difficulty in swallowing or of any gastrointestinal disease, which could affect drug absorption.
- Intolerance to venipuncture
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the volunteer's participation in this study.
- Institutionalized volunteer.
- Use of any prescribed medications (including simvastatin and pravastatin) within 14 days prior to the first dose of study medication.
- Use of any OTC products, vitamin and herbal products, etc., within 7 days prior to the first dose of study medication.
- Use of grapefruit and grapefruit containing products within 7 days prior to the first dose of study medication.
- Ingestion of any caffeine or xanthine products (i.e. coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.), recreational drugs, alcohol or other alcohol containing products within 48 hours prior to the first dose of study medication.
- Ingestion of any unusual diet, for whatever reason (e.g.: low sodium) for three weeks prior to the first dose of study medication.
- Volunteer having serum uric acid higher than the upper limit of normal range during screening.
- AST, ALT values are 1.1 times higher than the upper limit of normal range during screening.
Trial locations and contacts
1 site in 1 country.
About this study
Single dose oral bioequivalence study of Bempedoic Acid 180 mg Film Coated Tablet and Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets in healthy adult human subjects under fasting conditions.
- Being tested
- Bempedoic Acid Film Coated Tablet, Nilemdo® (Bempedoic Acid) Film-coated tablets
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bempedoic Acid Film Coated TabletDrug
1 tablet of 180 mg Bempedoic Acid
Nilemdo® (Bempedoic Acid) Film-coated tabletsDrug
1 tablet of 180 mg Bempedoic Acid
| Study group | Role | What they receive |
|---|---|---|
| Bempedoic Acid Film Coated Tablet | Experimental | Bempedoic Acid 180 mg Film Coated Tablet Receives: Drug: Bempedoic Acid Film Coated Tablet |
| Nilemdo® (Bempedoic Acid) Film-coated tablets | Active comparator | Nilemdo® (Bempedoic Acid) 180 mg Film-coated tablets Receives: Drug: Nilemdo® (Bempedoic Acid) Film-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured plasma concentration over the time span specified (Cmax)
The 90% confidence interval of the relative mean (geometric least square mean) of the test to reference product for Ln-transformed Pharmacokinetic parameters Cmax was to be within 80.00% to 125.00% for Bempedoic Acid to establish bioequivalence.
Measured: 72.00 hours
The area under the plasma concentration versus time curve was calculated using the linear trapezoidal linear interpolation rule from the zero time point to the last quantifiable concentration (AUCt)
The 90% confidence interval of the relative mean (geometric least square mean) of the test to reference product for Ln-transformed Pharmacokinetic parameters AUCt was to be within 80.00% to 125.00% for Bempedoic Acid to establish bioequivalence.
Measured: 72.00 hours
Secondary outcomes (4)
The area under the plasma concentration versus time curve from zero to infinity was calculated by adding Ct/Kel to AUCt, where Ct was the last quantifiable concentration and Kel was the elimination rate constant (AUCi)
Descriptive statistics
Measured: 72.00 hours
Time of the maximum measured plasma concentration. If the maximum plasma concentration occurs at more than one time point, the first was chosen as Tmax (Tmax)
Descriptive statistics
Measured: 72.00 hours
The terminal elimination rate constant was obtained from the slope of the line, fitted by linear least squares regression, through the terminal points of the natural log of the concentration versus time plot for these points (Kel)
Descriptive statistics
Measured: 72.00 hours
The half-life was calculated by the equation tHalf = 0.693/ Kel (tHalf)
Descriptive statistics
Measured: 72.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start4 Dec 2024
- Primary completion18 Dec 2024
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanis Saglık Anonim Sirketi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923956
- Sponsor's protocol ID
- C1B04874
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No