Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Edasalonexent 2000 mg TID
* Drug: Midazolam 2 MG/ML
* Drug: Deflazacort 36Mg Tab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years


Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2. | Drug: Midazolam 2 MG/ML<br>* 2 mg/ml syrup<br>Drug: Deflazacort 36Mg Tab<br>* 36 mg tablets<br>|
| Experimental: Treatment B<br>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. | Drug: Edasalonexent 2000 mg TID<br>* CAT-1004 capsules<br>Drug: Midazolam 2 MG/ML<br>* 2 mg/ml syrup<br>Drug: Deflazacort 36Mg Tab<br>* 36 mg tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC of edasalonexent with midazolam and deflazacort |  | 12 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QTc interval with edasalonexent |  | 12 Days | 
| Number of participants with reported treatment-related adverse events |  | 12 days |