At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 4 clinical trial evaluating Bempedoic Acid 180 MG Oral Tablet and Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet for Healthy Lactating Women. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Bempedoic Acid 180 MG Oral Tablet \[Nexletol\]
Bempedoic Acid/Ezetimibe 180 MG-10 MG Oral Tablet \[NEXLIZET\]