Healthy
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGEdasalonexent 2000 mg TID
CAT-1004 capsules
DRUGMidazolam 2 MG/ML
2 mg/ml syrup
DRUGDeflazacort 36Mg Tab
36 mg tablets
Sponsors
Catabasis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of edasalonexent with midazolam and deflazacort | 12 Days |
Secondary
| Measure | Time frame |
|---|---|
| QTc interval with edasalonexent | 12 Days |
| Number of participants with reported treatment-related adverse events | 12 days |
Countries
United States
Outcome results
None listed