Phase 4Completed
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)
- Sponsor
- Esperion Therapeutics, Inc. (Industry)
- Enrolment
- 16 enrolled
- Conditions
- Healthy Lactating Women
- Interventions
- Bempedoic Acid 180 MG Oral Tablet; Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet
- Ages
- adults
- Registry
- NCT06021951
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Daily Infant Dose
- Relative Infant Dose (RID)
History
Results first posted
Last registry update
Study completion
Primary completion
Registered
Started