drugset / Trial / NCT04543370

Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

NCT04543370

Phase 1 Completed 26 enrolled Catabasis Pharmaceuticals
Non-randomizedSingle-groupOpen-labelHealth-services research

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.

Timeline

Start
2020-08-08
Primary completion
2020-09-06
Completion
2020-10-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Deflazacort Other / unclassified 36 mg
Subject Edasalonexent Small molecule 2000 mg Oral
Subject Midazolam Small molecule 2 mg

Indications

No indication recorded.