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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | 2 mg midazolam on Day 1 and 36 mg deflazacort on Day 2. |
|
| Treatment B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Edasalonexent 2000 mg TID | Drug | CAT-1004 capsules |
| |
| Midazolam 2 MG/ML |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of edasalonexent with midazolam and deflazacort | 12 Days |
| Measure | Description | Time Frame |
|---|---|---|
| QTc interval with edasalonexent | 12 Days | |
| Number of participants with reported treatment-related adverse events | 12 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne Donovan, MD, PhD | Chief Medical Officer, Catabasis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion Clinical Research Unit | Tempe | Arizona | 85283 | United States |
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| ID | Term |
|---|---|
| C000622102 | edasalonexent |
| D008874 | Midazolam |
| C021988 | deflazacort |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
2 mg/ml syrup |
|
| Deflazacort 36Mg Tab | Drug | 36 mg tablets |
|
| D006571 | Heterocyclic Compounds |