NCT06021951已完成4 期
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)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Daily Infant Dose
研究概览
简要总结
This study is designed to characterize the excretion of bempedoic acid or bempedoic acid and ezetimibe into mature breast milk of healthy lactating women and assess the exposure to the breast fed infant by estimating the daily infant dosage and the relative infant dose (RID) of bempedoic acid or bempedoic acid and ezetimibe in breast milk after 6 consecutive daily doses of bempedoic acid or bempedoic acid/ezetimibe FCDP.
详细描述
Post marketing approval commitment for the FDA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Bempedoic acid
Experimental
干预措施: Bempedoic Acid 180 MG Oral Tablet (Drug)
Bempedoic acid/ezetimibe fixed combination drug product
Experimental
干预措施: Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet (Drug)
结局指标
主要结局
Daily Infant Dose
时间窗: 24 hours post Day 6 dose administration
Daily infant dosage of study drug was calculated for Bempedoic Acid arm and FCDP arm respectively from the cumulative amount of study drug (bempedoic acid or bempedoic acid and ezetimibe) excreted in breast milk over 24 hours.
Relative Infant Dose (RID)
时间窗: 24 hours post Day 6 dose administration
Relevant Infant Dose (RID) (calculated as the ratio of estimated infant daily dose per kg body weight and maternal daily dose per kg of body weight multiplied by 100) was analyzed for the Bempedoic Acid arm and FCDP arm respectively. Maternal dosage is the ratio of bempedoic acid dose or ezetimibe dose administered daily divided by maternal body weight at baseline.
次要结局
- Ctrough of Ezetimibe and Metabolite in Plasma(24 hours post Day 6 dose administration)
- Ctrough_milk/Ctrough_plasma (M/P Ratio) of Bempedoic Acid and Metabolites(24 hours post Day 6 dose administration)
- M/P Ratio of Ezetimibe and Metabolite(24 hours post Day 6 dose administration)
- Cumulative Amount of Bempedoic Acid (ETC-1002) and Metabolites (ESP-15228, ETC-1002-Glucuronide) in Breast Milk(24 hours post Day 6 dose administration)
- Cumulative Amount of Ezetimibe (EZE) and Metabolite (EZE-Glucuronide) in Breast Milk(24 hours post Day 6 dose administration)
- Maximum Concentrations (Cmax) of Bempedoic Acid and Metabolites in Breast Milk(24 hours post Day 6 dose administration)
- Cmax of Ezetimibe and Metabolite in Breast Milk(24 hours post Day 6 dose administration)
- Time of Maximum Concentration (Tmax) of Bempedoic Acid and Metabolites in Breast Milk(24 hours post Day 6 dose administration)
- Tmax of Ezetimibe and Metabolite in Breast Milk(24 hours post Day 6 dose administration)
- Area Under the Breast Milk Concentration-time Curve Over the 24-hour Collection Interval (AUC24h) of Bempedoic Acid and Metabolites in Breast Milk(24 hours post Day 6 dose administration)
- AUC24h of Ezetimibe and Metabolite in Breast Milk(24 hours post Day 6 dose administration)
- Average Concentration (Cavg) of Bempedoic Acid and Metabolites in Breast Milk(24 hours post Day 6 dose administration)
- Cavg of Ezetimibe and Metabolite in Breast Milk(24 hours post Day 6 dose administration)
- Trough Concentration (Ctrough) of Bempedoic Acid and Metabolites in Breast Milk(24 hours post Day 6 dose administration)
- Ctrough of Ezetimibe and Metabolite in Breast Milk(24 hours post Day 6 dose administration)
- Ctrough of Bempedoic Acid and Metabolites in Plasma(24 hours post Day 6 dose administration)
研究者
研究点 (1)
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