NCT06021951

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

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

Post marketing approval commitment for the FDA

Conditions

• Healthy Lactating Women

Interventions

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

Timeline

• Start date: 2023-08-04
• Primary completion: 2024-02-21
• Completion: 2024-03-22
• First posted: 2023-09-01
• Last updated: 2025-04-11
• Results posted: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study