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

NCT06021951 ↗

Phase 4 Completed 16 enrolled Esperion Therapeutics, Inc.

RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start: 2023-08-04
Primary completion: 2024-02-21
Completion: 2024-03-22

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bempedoic acid	Small molecule	180 mg	Oral
Subject	Ezetimibe	Unknown	10 mg	Oral

Indications

No indication recorded.