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

Post marketing approval commitment for the FDA

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.