Overview

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

Status:
COMPLETED

Trial end date:
2024-03-22

Target enrollment:

Participant gender:

Summary

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.

Phase:

PHASE4

Details

Lead Sponsor:

Esperion Therapeutics, Inc.

Treatments:

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Tablets