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

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor: Esperion Therapeutics, Inc.
Study ID: NCT06021951
Phase: PHASE4
Status: Completed

Conditions

Healthy Lactating Women

Eligibility Criteria

Sex: FEMALE
Age: 18 Years - 45 Years
Healthy Volunteers: Accepted

Interventions

Bempedoic Acid 180 MG Oral Tablet — DRUG
Bempedoic Acid 180 MG Oral Tablet \[Nexletol\]
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet — DRUG
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet \[NEXLIZET\]

Study Details

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.

Key Dates

Start date: Aug 4, 2023
Status verified: May 2024
Primary completion: Feb 21, 2024
Completion: Mar 22, 2024

Study Design

Enrollment: 16 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Arms

Experimental: Bempedoic acid
Experimental: Bempedoic acid/ezetimibe fixed combination drug product

Primary Outcome Measure

Daily Infant Dose [ Time Frame: 24 hours post Day 6 dose administration ]

Locations (1)

Facility	City	State	ZIP	Site coordinators
PPD Development, Las Vegas Research Unit	Las Vegas	Nevada	89113	-

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PPD Development, Las Vegas Research Unit· Las Vegas, NV