NCT04543370

Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Catabasis Pharmaceuticals · Industry
• Sex: —
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Edasalonexent 2000 mg TID	CAT-1004 capsules
DRUG	Midazolam 2 MG/ML	2 mg/ml syrup
DRUG	Deflazacort 36Mg Tab	36 mg tablets

Timeline

• Start date: 2020-08-08
• Primary completion: 2020-09-06
• Completion: 2020-10-01
• First posted: 2020-09-10
• Last updated: 2021-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study