Study of Edasalonexent With Midazolam and Deflazacort in Healthy Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Midazolam 2 MG/ML; Drug: Deflazacort 36Mg Tab; Drug: Edasalonexent 2000 mg TID

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.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion Clinical Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Catabasis Pharmaceuticals
• Investigators: Study Chair: Joanne Donovan, MD, PhD, Chief Medical Officer, Catabasis

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2020
• Primary Completion (ACTUAL): September 6, 2020
• Study Completion (ACTUAL): October 1, 2020

Study Registration Dates

• First Submitted: August 21, 2020
• First Submitted That Met QC Criteria: September 3, 2020
• First Posted (ACTUAL): September 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Midazolam; Deflazacort
• Other Study ID Numbers: CAT-1004-106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No