Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Catabasis Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Deflazacort 36Mg Tab; Drug: Edasalonexent 2000 mg TID; Drug: Midazolam 2 MG/ML

Study type: Interventional

Funder types: Industry

Identifiers

NCT04543370

CAT-1004-106

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

Treatment A

Experimental group

Description:

2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2.

Treatment:

Drug: Midazolam 2 MG/ML

Drug: Deflazacort 36Mg Tab

Treatment B

Experimental group

Description:

2000 mg edasalonexent TID on Day 1 to Day 11 with 2 mg midazolam on Day 10 and with 36 mg deflazacort on Day 11.

Treatment:

Drug: Midazolam 2 MG/ML

Drug: Deflazacort 36Mg Tab

Drug: Edasalonexent 2000 mg TID