Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04543370

Run by

Catabasis Pharmaceuticals

People needed

26

Starts

2020-08-08

Expected to finish

2020-10-01

Last updated by the study team

2021-01-28

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, adult, male or female (of non-childbearing potential), 18-55 years of age, inclusive at Screening
• Non-smoker
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 at Screening
• Medically healthy with no clinically significant medical history
• Ability to swallow multiple capsules/tablets.
• Ability to understand the study procedures, willing and able to comply with the protocol

You may not qualify if…

• History or presence of clinically significant medical condition or disease
• History or presence of hypersensitivity to edasalonexent or excipients based upon known allergies to compounds of a similar class such as salicylates, fish oil, eicosapentaenoic acid, or DHA
• History or presence of hypersensitivity to midazolam, deflazacort, or related compounds (e.g., steroids or their formulation including lactose).
• Participation in another clinical study within 30 days prior to the first dosing

Where it is running

• Celerion Clinical Research Unit — Tempe, Arizona, United States

Full record on ClinicalTrials.gov

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