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Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Healthy Clinical Trial

Official title:
A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects

Clinical Trial Summary

Drug-drug interaction (DDI) and Cardiodynamic Evaluation Study To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 [CYP]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects.

Clinical Trial Description

This is an open-label, fixed-sequence DDI and cardiodynamic study in healthy adult subjects. Twenty-six (26), healthy, adult male and female (non-childbearing potential) subjects will be enrolled. Screening of subjects will occur within 28 days prior to the first dosing. To assess the effect of multiple oral doses of edasalonexent on the single-dose pharmacokinetics (PK) of midazolam (a cytochrome P450 [CYP]3A4 sensitive substrate) and of deflazacort (a CYP3A4 moderate sensitive substrate) in healthy adult subjects. Visit assessments include Clinical laboratory tests, Safety ECGs and Cardiodynamic ECGs. Subjects will be housed on Day -3 of Period 1, until after the 24-hour blood draw and/or study procedures are completed on Day 12 of Period 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04543370
Study type Interventional
Source Catabasis Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date August 8, 2020
Completion date October 1, 2020
View Details
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