Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) in the Breast Milk of Healthy Lactating Women
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ClinicalTrials.gov Identifier: NCT06021951 |
Recruitment Status :
Completed
First Posted : September 1, 2023
Last Update Posted : May 13, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Lactating Women | Drug: Bempedoic Acid 180 MG Oral Tablet Drug: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | An Open-Label Postmarking Milk-Only Lactation Study to Evaluate the Concentration of Bempedoic Acid and Bempedoic Acid and Ezetimibe in the Breast Milk of Healthy Lactating Women Administered Therapeutic Doses of Bempedoic Acid or Bempedoic Acid/Ezetimibe Fixed Combination Drug Product (FCDP) |
Actual Study Start Date : | August 4, 2023 |
Actual Primary Completion Date : | February 21, 2024 |
Actual Study Completion Date : | March 22, 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Bempedoic acid |
Drug: Bempedoic Acid 180 MG Oral Tablet
Bempedoic Acid 180 MG Oral Tablet [Nexletol]
Other Name: Nexletol |
Experimental: Bempedoic acid/ezetimibe fixed combination drug product |
Drug: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet [NEXLIZET]
Other Name: Nexlizet 180 mg-10 mg |
- Daily infant dose (mg/d) [ Time Frame: Day 6 ]
- Relative infant dose (%) [ Time Frame: Day 6 ]
- Amount excreted in each breast milk collection, calculated as the product of concentration and milk volume collected [ Time Frame: Day 6 ]
- Area under the milk concentration-time curve (AUC) over a 24-hour collection interval [ Time Frame: Day 6 ]
- Average milk concentration based on milk AUC [ Time Frame: Day 6 ]
- Peak and trough milk concentrations and the time of peak milk concentrations [ Time Frame: Day 6 ]
- Plasma trough concentrations [ Time Frame: Day 6 ]
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- The subject must be a lactating female who had a normal full-term pregnancy and has been actively breastfeeding or pumping for at least 4 weeks; lactation must be well established per Investigator discretion.
- The subject must be willing to pump regularly during the study to maintain milk supply and discontinue breastfeeding for the entire 13-day Treatment and Washout Periods.
- The subject must not be pregnant.
- The subject must be surgically sterile or willing to use 1 acceptable method of birth control.
Exclusion Criteria:
- Has clinically significant infection (e.g., pneumonia, pyelonephritis) or chronic infection within 30 days prior to enrollment.
- Has evidence of unstable or uncontrolled, clinically significant cardiovascular, central nervous system, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder, including serious allergy, asthma, hypoxemia, hypertension, seizures, or allergic skin rash, that, in the opinion of the Investigator, would confound the study results or compromise subject safety.
- Has estimated glomerular filtration rate (eGFR) <30 mL/min/1.732 using the Modification of Diet in Renal Disease (MDRD) formula.
- Has liver disease or dysfunction characterized by Child-Pugh Class B or Class C.
- History of any major neurological disorders, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
- Has active psychiatric problems that, in the Investigator's opinion, may interfere with compliance with the study procedures.
- Has history of breast implants, breast augmentation, or breast reduction surgery.
- Has a prior history of difficulty establishing lactation.
- Gastrointestinal conditions or procedures (including weight loss surgery; e.g., Lap-Band® or gastric bypass) that may affect drug absorption.
- Any history of malignancy (with the exception only of basal or squamous cell carcinoma of the skin in individuals that have been cancer free for >5 years).
- History within the last 2 years of drug, alcohol, amphetamine and derivatives, or cocaine abuse.
- Current smoker.
- Blood donation, participation in a multiple blood draw clinical study, major trauma, or surgery with or without blood loss within 30 days prior to enrollment.
- Blood transfusion for any reason within 90 days prior to enrollment.
- Use of any 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor (statin) concurrently or within 30 days prior to randomization.
- Use of cyclosporine, cholestyramine, probenecid, fibrate drugs, or medications contraindicated during lactation concurrently or within 30 days prior to randomization.
- Concomitant use or use within 30 days prior to randomization of drugs that decrease breast milk production, such as pseudoephedrine.
- Concomitant use or use within 30 days prior to randomization of drugs that increase breast milk production, such as domperidone.
- Use of any experimental or investigational drugs/vaccines concurrently or within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021951
United States, Nevada | |
PPD Development, Las Vegas Research Unit | |
Las Vegas, Nevada, United States, 89113 |
Study Director: | Christine Broestl, MS | Esperion Therapeutics, Inc. |
Responsible Party: | Esperion Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT06021951 |
Other Study ID Numbers: |
1002FDC-075 |
First Posted: | September 1, 2023 Key Record Dates |
Last Update Posted: | May 13, 2024 |
Last Verified: | May 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Bempedoic acid Ezetimibe Bempedoic acid and ezetimibe Breast Milk |
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid Ezetimibe Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors Hypoglycemic Agents Physiological Effects of Drugs |