Clinical trial NCT04543370: Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects
Official title: A Phase 1, Open-Label Study to Evaluate CYP3A4 Drug-Drug Interactions of Edasalonexent in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Catabasis Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2020-09-10
Enrollment: 26
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: AUC of edasalonexent with midazolam and deflazacort
timeFrame: 12 Days
Secondary outcomes:
measure: QTc interval with edasalonexent
timeFrame: 12 Days
measure: Number of participants with reported treatment-related adverse events
timeFrame: 12 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion Clinical Research Unit
state: Arizona
Study officials:
affiliation: Chief Medical Officer, Catabasis
name: Joanne Donovan, MD, PhD
role: STUDY_CHAIR
References: