Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

• Status: Completed
• Trial end date: 2020-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Catabasis Pharmaceuticals
• Treatments: Deflazacort; Midazolam

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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